Apparatus, method and article to perform assays using assay strips

ABSTRACT

An assay system includes an optical imager to acquire high resolution images of assay strips (e.g., lateral flow immunochromatographic test strips) and performs image processing to identify individual assay strips and determine results for each assay strip, by quantifies the presence or absence of test signal line(s) and control signal line(s). Assay strips may be in a holder or carrier contained in a specimen container also holding a specimen. The assay system automatically logs all results and data to a database that stores a high resolution image of the original immunochromatographic assay, the values of test line(s) and control line(s), and the test result. A user interface directs an end user through operation.

BACKGROUND

1. Technical Field

The present disclosure generally relates to the performance of assaysusing assay strips, for example chromatographic lateral flow strips.

2. Description of the Related Art

Performance of biological assays has been by greatly facilitated by theintroduction of substrates for performing chromatographic assays. Sinceits conception, numerous substrates have been proposed for performingchromatographic assays. Such substrates are commonly referred to assaytest strips or immunochromatographic strips. One type of assay strip iscommonly referred to as chromatographic lateral flow strips or lateralflow strips. Other types of assay strips include western blots, southernblots, electrophoresis gels, dot blots, etc. Assay strips may be usedfor both qualitative and semi-quantitative assays, which typicallyemploy visual detection schemes.

Assay strips typically provide a matrix of material through which afluid test sample, which may or may not contain an analyte that is beingtested for, can flow. In use, a liquid test sample suspected ofcontaining an analyte to be detected is applied to an application zoneof the assay strip. In the case of lateral flow strips, the test fluidand analyte suspended or dissolved therein can flow from the applicationzone to a detection zone, for example via capillary action. The testfluid typically flows horizontally though the matrix (i.e., laterally),although vertical layers may be employed. At the detection zone theappearance or absence of a visible signal (e.g., test results signalline) reveals the presence or absence of the analyte. Assay stripstypically visually display two parallel lines, known as capture orsignal lines. One of the lines indicates that test strip performance hasnot been compromised. The second line becomes visible only when thesample contains an amount of analyte in excess of a minimum or thresholdconcentration. In such assay strips, the capture or signal lines consistof immobilized capture reagents or receptors which are pre-applied tothe matrix during manufacture.

In particular, lateral flow type assay strips may include a bindingpartner that immunospecifically binds the analyte to be detected andwhich bears a detectable label. The binding may be competitive bindingor non-competitive. Competitive assays are particularly suited to detectsmaller molecules, such as drugs and drug metabolites. Non-competitiveimmunoassays are primarily used for detection of large molecules such asproteins, large hormones, or molecules which have multiple bindingsites. The detection zone may include a substrate for a label capable ofproviding a colored response in the presence of the label. The assaystrip may also contain a zone in which analyte is immobilized so thatlabeled binding partner which is not combined due to an absence ofanalyte in the sample will be captured and prevented from reaching thedetection zone. Multi-zone assay strips are also known, which mayinclude a detection zone that contains an immobilized form of a bindingsubstance for a labeled reagent. The labeled reagent bears a detectablechemical group having a detectable physical property so that it does notrequire a chemical reaction with another substance. Examples of suchinclude colored species, fluorescers, phosphorescent molecules,radioisotopes and electro-active moieties.

Results have traditionally been interpreted visually by the operator.Resulting test and control signal lines vary greatly in intensity,resulting in highly subjective user analysis. Even positive results maybe indicated by an extremely faint, but present, test results signalline. In such circumstances, some operators may visually conclude thatno test line is present, while other operators may correctly identifythe presence of a test line. The issue is further clouded by the natureof assay strips which sometimes contain a high level of backgroundcolor, that may be incorrectly identified as a positive test line. Thus,assay strips typically provide results which are at bestsemi-quantitative and are typically subject to variance by the personperforming the assay. Since quantification cannot be performedaccurately with the naked eye and hence an exact amount of an analytecannot be determined, application is restricted. Thus, while assay stripformats provide rapid results, are simple to operate, and are morecost-effective than conventional formats, such formats are typically notsubject to quantification.

Different approaches to performing assays using assay strips aredesirable, particular ones that address some of the above describedproblems, as well as approaches that address other problems.

BRIEF SUMMARY

At least one aspect may be summarized as an assay system to performassays using assay strips, including a housing having an interior and atleast one entrance providing access to the interior, the at least oneentrance sized to receive at least one assay strip therein without anyassay strip carrier; an imager subsystem operable to capture images ofany of the assay strips received in the interior of the housing; and aprocessor subsystem comprising at least one processor and at least oneprocessor-readable memory communicatively coupled to the at least oneprocessor, the at least one processor also communicatively coupled tothe imager subsystem to receive image information representative of theimages captured by the imager subsystem, the at least one processorconfigured to identify individual ones of the assay strips in the imagefrom the image information, the at least one processor furtherconfigured to perform an objective assay evaluation based at least inpart on at least one signal line on each of the assay strips and basedat least in part on at least one configurable criteria.

At least one processor may be configured to store a respective highresolution digital representation of the captured image of each of atleast some of the assay strips to a computer-readable storage mediumalong with at least some identification information logically associatedwith the respective high resolution digital representation of thecaptured image of each of the at least some of the assay strips.

At least one processor may be configured to store a respective highresolution digital representation of the captured image of each of atleast some of the assay strips to a computer-readable storage mediumalong with at least some information indicative of a result of theobjective assay evaluation for each of at least some of the assay stripslogically associated with the respective high resolution digitalrepresentation of the captured image of each of the at least some of theassay strips.

The assay system may include the computer-readable storage medium. Theassay system may include a port that removably communicatively couplesto the computer-readable storage medium and that is configured to writeto the computer-readable storage medium.

The at least one processor may be configured to identify individual onesof the assay strips in the image from the image information, by: a firstiteration of pixel transformation based on a first color of a pluralityof pixels; a first iteration of blob analysis on a set of the pluralityof pixels resulting from the first iteration of pixel transformation toidentify a first number of blobs; and a first iteration of blob pairingon the first number of blobs identified in the first iteration of blobanalysis.

The at least one processor may be configured to identify individual onesof the assay strips in the image from the image information, further by:a second iteration of pixel transformation based on a second color of aplurality of pixels; a second iteration of blob analysis on a set of theplurality of pixels resulting from the second iteration of pixeltransformation to identify a second number of blobs; and a seconditeration of blob pairing on the second number of blobs identified inthe second iteration of blob analysis. Additional iterations may beperformed.

The at least one processor may be configured to identify anymachine-readable symbols in the image from the image information, and todecode the identified machine-readable symbols, if any. At least someinformation decoded from the identified machine-readable symbols may bethe identification information, and the at least one processor may beconfigured to logically associate the identification information withrespective ones of the assay strips which carried the machine-readablesymbol.

The assay system may include a user interface including a number of userselectable inputs that correspond to respective ones of a number ofconfiguration modes, each of the configuration modes mapped to arespective type of assay strip, where in response to selection of one ofthe user selectable inputs the processor subsystem reconfigures the atleast one configurable criteria. The at least one configurable criteriamay include a threshold level for the objective assay evaluation. The atleast one configurable criteria may include at least one aspect of aphysical format of the assay strips of the respective type of assaystrip. At least two of the configuration modes may be mapped torespective assay strips from at least two different flow strip producingcommercial entities.

The at least one processor may be configured to perform the objectiveassay evaluation by objectively quantifying an intensity of at least onepositive results signal line on each of the assay strips. The at leastone processor may be configured to perform the objective assayevaluation by evaluating at least one control signal line on each of theassay strips.

The image subsystem may include a two dimensional array that images anarea greater than an area of a single assay strip. The image subsystemmay include a one dimensional array mounted for movement with respect tothe at least one assay strip to image an area greater than an area of asingle assay strip. The interior of the housing may be dark and theimage subsystem may include a least one of a mirror, a prism, an opticalfilter or an image processing filter.

At least one aspect may be summarized as a method of operating an assaysystem to perform assays of assay strips, including receiving a numberof assay strips in an interior of a housing; capturing at least oneimage of a portion of the interior of the housing in which the assaystrips are received; computationally identifying individual ones of theassay strips in the captured image; and computationally performing theobjective assay evaluation for each of the identified individual ones ofthe assay strips that appear in the captured image based at least inpart on a representation of at least one signal line of each of theassay strips in the captured image. The captured image may be a highresolution image.

The entrance may include a plurality of slots, each slot sized anddimensioned to receive a respective one of the assay strips therein.

Receiving a number of assay strips in an interior of a housing mayinclude receiving a plurality of assay strips in the housing arrangedsuch that at least a portion of each of a plurality of flow strips isexposed to an imager. Capturing at least one image in the interior ofthe housing may include capturing at least one image of an area in theinterior of the housing having a dimension that is greater than adimension of a single assay strip. Capturing at least one highresolution image in the interior of the housing may include capturing atleast one high resolution image of an area in the interior of thehousing having a length and a width that is greater than a length and awidth of at least two adjacent assay strips.

Computationally identifying individual ones of the assay strips in thecaptured high resolution image may include performing a first iterationof pixel transformation based on a first color of a plurality of pixelsin the high resolution image; performing a first iteration of blobanalysis on a of the plurality of pixels resulting from the firstiteration of pixel transformation to identify a first number of blobs;and performing a first iteration of blob pairing on the first number ofblobs identified in the first iteration of blob analysis.Computationally identifying individual ones of the assay strips in thecaptured image may include performing a second iteration of pixeltransformation based on a second color of a plurality of pixels;performing a second iteration of blob analysis on a of the plurality ofpixels resulting from the second iteration of pixel transformation toidentify a second number of blobs; and performing a second iteration ofblob pairing on the second number of blobs identified in the seconditeration of blob analysis.

The method may further include identifying any machine-readable symbolsin the captured high resolution image; and decoding the identifiedmachine-readable symbols, if any. The method may further includelogically associating identification information decoded from theidentified machine readable symbols with respective ones of the assaystrips which appear in the high resolution image. The method may furtherinclude storing a respective digital representation of a portion of thecaptured high resolution image of each of at least some of the assaystrips to a computer-readable storage medium along with at least someidentification information logically associated with the respectivedigital representation of the respective portion of the captured highresolution image of each of the at least some of the assay strips.

The method may further include storing a respective digitalrepresentation of a portion of the captured high resolution image ofeach of at least some of the assay strips to a computer-readable storagemedium along with at least some information indicative of a result ofthe objective assay evaluation for each of at least some of the assaystrips logically associated with the respective digital representationof the respective portion of the captured high resolution image of eachof the at least some of the assay strips. The storing may includestoring to a removable computer-readable storage medium.

The method may further include computationally performing the objectiveassay evaluation for each of the identified individual ones of the assaystrips that appear in the captured high resolution image based at leastin part on a representation of at least one signal line of each of theassay strips in the captured high resolution image. Such may includeobjectively quantifying an intensity of at least one positive resultssignal line on each of the assay strips represented in the captured highresolution image. Such may further include evaluating at least onecontrol signal line on each of the assay strips represented in thecaptured high resolution image.

At least one aspect may be summarized as a computer-readable medium thatstores instructions that cause an assay system to perform assays ofassay strips, by: capturing at least one high resolution image of aportion of the interior of the housing in which a number of assay stripsare received; computationally identifying individual ones of the assaystrips in the captured high resolution image; and computationallyperforming the objective assay evaluation for each of the identifiedindividual ones of the assay strips that appear in the captured highresolution image based at least in part on a representation of at leastone signal line of each of the assay strips in the captured highresolution image.

Computationally identifying individual ones of the assay strips in thecaptured high resolution image may include performing a first iterationof pixel transformation based on a first color of a plurality of pixelsin the high resolution image; performing a first iteration of blobanalysis on a of the plurality of pixels resulting from the firstiteration of pixel transformation to identify a first number of blobs;and performing a first iteration of blob pairing on the first number ofblobs identified in the first iteration of blob analysis.

Computationally identifying individual ones of the assay strips in thecaptured image may include performing a second iteration of pixeltransformation based on a second color of a plurality of pixels;performing a second iteration of blob analysis on a of the plurality ofpixels resulting from the second iteration of pixel transformation toidentify a second number of blobs; and performing a second iteration ofblob pairing on the second number of blobs identified in the seconditeration of blob analysis. Computationally identifying individual onesof the assay strips in the captured image may include performing asecond iteration of pixel transformation based on additionally colors(e.g., a tertiary color).

The instructions may cause the assay system to perform assays of assaystrips, further by: identifying any machine-readable symbols in thecaptured high resolution image; and decoding the identifiedmachine-readable symbols, if any. The instructions may cause the assaysystem to perform assays of assay strips, further by: logicallyassociating identification information decoded from the identifiedmachine readable symbols with respective ones of the assay strips whichappear in the high resolution image. The instructions may cause theassay system to perform assays of assay strips, further by: storing arespective digital representation of a portion of the captured highresolution image of each of at least some of the assay strips to acomputer-readable storage medium along with at least some identificationinformation logically associated with the respective digitalrepresentation of the respective portion of the captured high resolutionimage of each of the at least some of the assay strips. The instructionsmay cause the assay system to perform assays of assay strips, furtherby: storing a respective digital representation of a portion of thecaptured high resolution image of each of at least some of the assaystrips to a computer-readable storage medium along with at least someinformation indicative of a result of the objective assay evaluation foreach of at least some of the assay strips logically associated with therespective digital representation of the respective portion of thecaptured high resolution image of each of the at least some of the assaystrips.

Computationally performing the objective assay evaluation for each ofthe identified individual ones of the assay strips that appear in thecaptured high resolution image based at least in part on arepresentation of at least one signal line of each of the assay stripsin the captured high resolution image may include objectivelyquantifying an intensity of at least one positive results signal line oneach of the assay strips represented in the captured high resolutionimage. Computationally performing the objective assay evaluation foreach of the identified individual ones of the assay strips that appearin the captured high resolution image based at least in part on arepresentation of at least one signal line of each of the assay stripsin the captured high resolution image may include evaluating at leastone control signal line on each of the assay strips represented in thecaptured high resolution image.

At least one aspect may be summarized as an assay system to performassays using assay strips, including a housing an entrance sized toreceive at least one assay strip therein; an imager subsystem operableto capture images of any of the assay strips received in the interior ofthe housing; and a processor subsystem comprising at least one processorcommunicatively coupled to the imager subsystem to receive imageinformation representative of the images captured by the imagersubsystem, the at least one processor configured to perform an objectiveassay evaluation based at least in part on at least one test resultssignal line and at least one control signal line on each of the assaystrips and based at least in part on at least one configurable criteria;and a user interface including a number of user selectable inputs thatcorrespond to respective ones of a number of configuration modes, eachof the configuration modes mapped to a respective type of assay strip,where in response to selection of one of the user selectable inputs theprocessor subsystem reconfigures the at least one configurable criteriaused to perform the objective assay evaluation.

The at least one configurable criteria may include a threshold level toobjectively evaluate the test results signal line. The at least oneconfigurable criteria may include at least one aspect of a physicalformat of the assay strips of the respective type of assay strip. Atleast two of the configuration modes may be mapped to respective assaystrips of at least two different types. At least two of theconfiguration modes may be mapped to respective assay strips of at leasttwo different immunochromatographic tests. At least two of theconfiguration modes may be mapped to respective assay strips from atleast two different assay strip producing commercial entities. The userinterface may include indicia indicative of a plurality of differentassay strip products. The user interface may include at least one inputdevice configured to allow the entry of a subject identifier thatuniquely identifies a subject from which a sample on the assay strip wastaken, and a logical association between the objective assay evaluationof the assay strip and the subject identifier may be stored. The atleast one processor may be configured to perform the objective assayevaluation by objectively quantifying an intensity of at least onepositive results signal line on each of the assay strips. The at leastone processor may be configured to perform the objective assayevaluation by evaluating at least one control signal line on each of theassay strips. The entrance may include a plurality of slots, each slotsized and dimensioned to receive a respective one or the assay stripstherein.

At least one aspect may be summarized as a method of operating an assaysystem to perform assays of assay strips, including receiving a userinput indicative of at least one value of at least one configurablecriteria to be used in performing an objective assay evaluation;receiving a number of assay strips in an interior of a housing;capturing at least one image a portion of the interior of the housing inwhich the assay strips are received; and computationally performing theobjective assay evaluation for each of the assay strips in the capturedimage based at least in part on a representation of at least one signalline of each of the assay strips in the captured image and based atleast in part on the user input indicative of the at least one value ofat least one user configurable criteria.

Receiving a user input indicative of at least one value of at least oneconfigurable criteria to be used in performing an objective assayevaluation may include receiving a user input indicative of a thresholdlevel for the objective assay evaluation. Receiving a user inputindicative of at least one value of at least one configurable criteriato be used in performing an objective assay evaluation may includereceiving a user input indicative of a threshold intensity level for apositive results signal line. Receiving a user input indicative of atleast one value of at least one configurable criteria to be used inperforming an objective assay evaluation may include receiving a valueindicative of a physical format of the assay strips of the respectivetype of assay strip. Receiving a user input indicative of at least onevalue of at least one configurable criteria to be used in performing anobjective assay evaluation may include receiving a value indicative of atype of assay strip. Receiving a user input indicative of at least onevalue of at least one configurable criteria to be used in performing anobjective assay evaluation may include receiving a value indicative of aassay strip manufacturer. Receiving a number of assay strips in aninterior of a housing may include receiving a plurality of assay stripsin the housing arranged such that at least a portion of each of aplurality of flow strips is exposed to an imager.

Capturing at least one image in the interior of the housing may includecapturing at least one image of an area in the interior of the housinghaving a dimension that is greater than a dimension of a single assaystrip. Capturing at least one image in the interior of the housing mayinclude capturing at least one image of an area in the interior of thehousing having a length and a width that is greater than a length and awidth of at least two adjacent assay strips.

The method may further include computationally identifying individualones of the assay strips in the captured image. The method may furtherinclude receiving a user input indicative of at least one value of atleast one configurable criteria to be used in performing an objectiveassay evaluation includes receiving an end user input via a userinterface.

The method may further include reading a subject identifier in the formof a piece of biometric information or a piece of government issuedidentification; and storing a logical association between the objectiveassay evaluation of the assay strip and the subject identifier.

At least one aspect may be summarized as a computer-readable medium thatstores instructions that cause an assay system to perform assays ofassay strips, by: receiving a user input indicative of at least onevalue of at least one configurable criteria to be used in performing anobjective assay evaluation; receiving a number of assay strips in aninterior of a housing; capturing at least one image a portion of theinterior of the housing in which the assay strips are received; andcomputationally performing the objective assay evaluation for each ofthe assay strips in the captured image based at least in part on arepresentation of at least one signal line of each of the assay stripsin the captured image and based at least in part on the user inputindicative of the at least one value of at least one user configurablecriteria.

Receiving a user input indicative of at least one value of at least oneconfigurable criteria to be used in performing an objective assayevaluation may include receiving a user input indicative of a thresholdlevel for the objective assay evaluation. Receiving a user inputindicative of at least one value of at least one configurable criteriato be used in performing an objective assay evaluation may includereceiving a user input indicative of a threshold intensity level for apositive results signal line. Receiving a user input indicative of atleast one value of at least one configurable criteria to be used inperforming an objective assay evaluation may include receiving a valueindicative of a physical format of the assay strips of the respectivetype of assay strip. Receiving a user input indicative of at least onevalue of at least one configurable criteria to be used in performing anobjective assay evaluation may include receiving a value indicative of atype of assay strip. Receiving a user input indicative of at least onevalue of at least one configurable criteria to be used in performing anobjective assay evaluation may include receiving a value indicative of aassay strip manufacturer. Receiving a number of assay strips in aninterior of a housing may include receiving a plurality of assay stripsin the housing arranged such that at least a portion of each of aplurality of flow strips is exposed to an imager.

Capturing at least one image in the interior of the housing may includecapturing at least one image of an area in the interior of the housinghaving a dimension that is greater than a dimension of a single assaystrip. Capturing at least one image in the interior of the housing mayinclude capturing at least one image of an area in the interior of thehousing having a length and a width that is greater than a length and awidth of at least two adjacent assay strips.

The instructions stored on the computer-readable may further cause aprocessor(s) to computationally identify individual ones of the assaystrips in the captured image. Receiving a user input indicative of atleast one value of at least one configurable criteria to be used inperforming an objective assay evaluation may include receiving an enduser input via a user interface.

An assay system to perform assays using assay strips may be summarizedas including a housing having an interior and at least one entranceproviding access to the interior, the at least one entrance sized toreceive at least one container containing a specimen and an assay stripcarrier that holds at least one assay strip; an imager subsystemoperable to capture images of any of the assay strips received in theinterior of the housing; and a processor subsystem comprising at leastone processor and at least one processor-readable memory communicativelycoupled to the at least one processor, the at least one processor alsocommunicatively coupled to the imager subsystem to receive imageinformation representative of the images captured by the imagersubsystem, the at least one processor configured to identify individualones of the assay strips in the image from the image information, the atleast one processor further configured to perform an objective assayevaluation based at least in part on at least one signal line on each ofthe assay strips and based at least in part on at least one configurablecriteria. The at least one processor may be further configured to storea respective high resolution digital representation of the capturedimage of each of at least some of the assay strips to acomputer-readable storage medium along with at least some identificationinformation logically associated with the respective high resolutiondigital representation of the captured image of each of the at leastsome of the assay strips. The at least one processor may be furtherconfigured to store a respective high resolution digital representationof the captured image of each of at least some of the assay strips to acomputer-readable storage medium along with at least some informationindicative of a result of the objective assay evaluation for each of atleast some of the assay strips logically associated with the respectivehigh resolution digital representation of the captured image of each ofthe at least some of the assay strips. The at least one processor may beconfigured to identify individual ones of the assay strips in the imagefrom the image information, by a first iteration of pixel transformationbased on a first color of a plurality of pixels; a first iteration ofblob analysis on a set of the plurality of pixels resulting from thefirst iteration of pixel transformation to identify a first number ofblobs; a first iteration of blob pairing on the first number of blobsidentified in the first iteration of blob analysis; a second iterationof pixel transformation based on a second color of a plurality ofpixels; a second iteration of blob analysis on a set of the plurality ofpixels resulting from the second iteration of pixel transformation toidentify a second number of blobs; and a second iteration of blobpairing on the second number of blobs identified in the second iterationof blob analysis. Additional iterations of pixel transformation based onadditional colors of the plurality of pixels may be performed. The atleast one processor may be further configured to identify anymachine-readable symbols in the image from the image information, and todecode the identified machine-readable symbols, if any.

The assay system may further include a user interface including a numberof user selectable inputs that correspond to respective ones of a numberof configuration modes, where in response to selection of one of theuser selectable inputs the processor subsystem may reconfigure the atleast one configurable criteria. The user interface may include at leastone input device configured to allow the entry of a subject identifierthat uniquely identifies a subject from which a sample on the assaystrip was taken, and wherein the at least one processor may beconfigured to store a logical association between the objective assayevaluation of the assay strip and the subject identifier. The userinterface may include at least one input device configured to allow theentry of a selection that identifies a type of data carrier, and whereinthe at least one processor may be configured to process based on thetype of data carrier indicated by the entry. The image subsystem mayinclude a two dimensional array that images an area greater than an areaof a single assay strip.

A method of operating an assay system to perform assays of assay stripsmay be summarized as including receiving a container enclosing aspecimen along with number of assay strips in an interior of a housing;capturing at least one high resolution image of a portion of theinterior of the housing in which the assay strips are received;computationally identifying individual ones of the assay strips in thecaptured high resolution image; and computationally performing theobjective assay evaluation for each of the identified individual ones ofthe assay strips that appear in the captured high resolution image basedat least in part on a representation of at least one signal line of eachof the assay strips in the captured high resolution image. Capturing atleast one high resolution image in the interior of the housing mayinclude capturing at least one high resolution image of an area in theinterior of the housing having a length and a width that is greater thana length and a width of at least two adjacent assay strips.Computationally identifying individual ones of the assay strips in thecaptured high resolution image may include performing a first iterationof pixel transformation based on a first color of a plurality of pixelsin the high resolution image; performing a first iteration of blobanalysis on a of the plurality of pixels resulting from the firstiteration of pixel transformation to identify a first number of blobs;performing a first iteration of blob pairing on the first number ofblobs identified in the first iteration of blob analysis; performing asecond iteration of pixel transformation based on a second color of aplurality of pixels; performing a second iteration of blob analysis on aof the plurality of pixels resulting from the second iteration of pixeltransformation to identify a second number of blobs; and performing asecond iteration of blob pairing on the second number of blobsidentified in the second iteration of blob analysis.

The method may further include identifying any machine-readable symbolsin the captured high resolution image; decoding the identifiedmachine-readable symbols, if any; and logically associatingidentification information decoded from the identified machine readablesymbols with respective ones of the assay strips which appear in thehigh resolution image.

The method may further include storing a respective digitalrepresentation of a portion of the captured high resolution image ofeach of at least some of the assay strips to a computer-readable storagemedium along with at least some identification information logicallyassociated with the respective digital representation of the respectiveportion of the captured high resolution image of each of the at leastsome of the assay strips.

The method may further include storing a respective digitalrepresentation of a portion of the captured high resolution image ofeach of at least some of the assay strips to a computer-readable storagemedium along with at least some information indicative of a result ofthe objective assay evaluation for each of at least some of the assaystrips logically associated with the respective digital representationof the respective portion of the captured high resolution image of eachof the at least some of the assay strips.

The method may further include reading a subject identifier in the formof a piece of biometric information or a piece of government issuedidentification; and storing a logical association between the objectiveassay evaluation of the assay strip and the subject identifier.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not drawn to scale, and some of these elementsare arbitrarily enlarged and positioned to improve drawing legibility.Further, the particular shapes of the elements as drawn, are notintended to convey any information regarding the actual shape of theparticular elements, and have been solely selected for ease ofrecognition in the drawings.

FIG. 1 is an isometric view of an assay system to perform assays,including an assay device, a computing system, and a barcode reader,according to one illustrated embodiment.

FIG. 2 is a functional block diagram of an assay system including anassay device, peripheral computing system, symbol reader, and a servercomputing system providing communications therebetween, according toanother illustrated embodiment.

FIG. 3 is an isometric diagram of a number of test strips positioned tobe read by an imager in the form of a two-dimensional imager array,according to one illustrated embodiment.

FIG. 4 is an isometric diagram of a number of test strips positioned tobe read by a one-dimensional imager, driven by a motor to move withrespect to the test strips, according to one illustrated embodiment.

FIG. 5 is an isometric diagram of a number of test strips positioned tobe read by a number of imagers that employs mirrors or prisms and lensesaccording to another illustrated embodiment.

FIG. 6 is a flow diagram of a method of operating an assay systemaccording to one illustrated embodiment including receiving assaystrips, capturing high resolution images, computationally identifyingindividual strips, and computationally performing objective assayevaluations.

FIG. 7 is a flow diagram showing a method of receiving assay strips,according to one illustrated embodiment.

FIG. 8 is a flow diagram showing a method of capturing an image of assaystrips, according to one illustrated embodiment.

FIG. 9 is a flow diagram showing a method of capturing images of assaystrips according to another illustrated embodiment.

FIG. 10A is a flow diagram showing a method of operating an assay deviceaccording to one illustrated embodiment, including computationallyidentifying individual assay strips in an acquired high resolutionimage.

FIG. 10B is a flow diagram showing a method of objectively quantifyingat least one positive results signal line and/or evaluating at least onecontrol signal line represented in the high resolution image, accordingto one illustrated embodiment.

FIG. 10C is a flow diagram showing a method of adaptively narrowing awindow to eliminate shadows at edges of the window, according to oneillustrated embodiment.

FIG. 10D is a graph representing the interrelationship of variousparameters and variables in performing an assay, according to oneillustrated embodiment.

FIG. 11 is a flow diagram of a method of performing assays, according toanother illustrated embodiment including receiving user input, receivingassay strips, capturing images and computationally performing objectiveassay evaluation based on the user input.

FIG. 12 is a flow diagram showing a method of receiving user inputaccording to one illustrated embodiment.

FIG. 13 is a flow diagram showing a method of receiving user inputaccording to another illustrated embodiment.

FIG. 14 is a flow diagram showing a method of receiving user inputaccording to a further illustrated embodiment.

FIG. 15 is a flow diagram showing a method of receiving user inputaccording to yet a further illustrated embodiment.

FIG. 16 is a flow diagram showing a method of receiving user inputaccording to yet an even further illustrated embodiment.

FIG. 17 is a screen print showing an introductory screen of a portion ofa user interface of the assay device, according to one illustratedembodiment.

FIG. 18 is a screen print showing a STEP 1 screen of the user interfaceof the assay device, according to one illustrated embodiment.

FIG. 19 is a screen print showing a STEP 2 screen of a user interface ofthe assay device, according to one illustrated embodiment.

FIG. 20 is a screen print showing the STEP 2 screen of FIG. 19 afterselection of the start timer icon.

FIG. 21 is a screen print showing a STEP 3 screen of a user interface ofan assay device, according to one illustrated embodiment.

FIG. 22 is a screen print showing a results screen of a user interfaceof an assay device for an assay strip having a positive result,according to on illustrated embodiment.

FIG. 23 shows a details screen for the particular assay strip of FIG.22.

FIG. 24 is a screen print showing the details screen for an assay stripin which a negative result was determined.

FIG. 25 is a screen print showing a details screen of a user interfaceof an assay device, according to another illustrated embodiment.

FIG. 26 is a screen print showing a first instructions screen of a userinterface of an assay device, according to another illustratedembodiment.

FIG. 27 is a screen print showing a second instructions screen of a userinterface of an assay device, according to one illustrated embodiment.

FIG. 28 is a screen print showing a third instructions screen of a userinterface of an assay device according to one illustrated embodiment.

FIG. 29 is a screen print showing a fourth instructions screen of a userinterface of an assay device, according to one illustrated embodiment.

FIG. 30 is a screen print showing a fifth instructions screen of a userinterface of an assay device, according to one illustrated embodiment.

FIG. 31 is a screen print showing a sixth instructions screen of a userinterface of an assay device, according to one illustrated embodiment.

FIG. 32 is a screen print showing a seventh instructions screen of auser interface of an assay device, according to one illustratedembodiment.

FIG. 33 is a screen print showing an eighth instructions screen of auser interface of an assay device, according to one illustratedembodiment.

FIG. 34 is a screen print showing an analyzing screen, according to oneillustrated embodiment, which may be displayed while the assay deviceperforms analysis, providing the end user visual feedback indicatingthat the assay device is processing samples.

FIG. 35 is a screen print showing a portion of a graphical user toselect manufacturer/distributors and/or model/product, according to oneillustrated embodiment.

FIG. 36 is a screen print showing a portion of a graphical user toselect format options and choices, according to one illustratedembodiment.

FIG. 37 is a schematic diagram of a report generated by assay systemaccording to one illustrated embodiment, the report includingidentification information, a summary of assay results, a detailedlisting of assay results and an image of assay strip(s) in a specimenholder used to test for multiple banned substances from a singlespecimen.

FIG. 38 is an isometric view of an assay system according to anotherillustrated embodiment for use with a container that holds a specimenand one or more assay strips.

FIG. 39 is an isometric view according to one illustrated embodiment, ofa container which holds a specimen and an assay carrier which holds anumber of assay strips and which bears human-readable information.

FIG. 40 is a screen print of a configuration screen of a user interfaceof the assay system of FIG. 38, according to one illustrated embodiment,the configuration screen allowing the user to configure the assay system3800 to process different types of container, strip carriers and/orassay strips.

FIG. 41 is a screen print of an information entry screen of a userinterface of the assay system of FIG. 38, according to one illustratedembodiment.

FIG. 42 is a screen print of a results screen of a user interface of theassay system of FIG. 38, according to one illustrated embodiment.

FIG. 43 is a schematic diagram of a database according to oneillustrated embodiment, the database storing information about variousones of the tests or assays along with a copy of a high resolution imageon which the tests or assays were based.

DETAILED DESCRIPTION

In the following description, certain specific details are set forth inorder to provide a thorough understanding of various disclosedembodiments. However, one skilled in the relevant art will recognizethat embodiments may be practiced without one or more of these specificdetails, or with other methods, components, materials, etc. In otherinstances, well-known structures associated with apparatuses, methodsand articles for performing assays using lateral flow strips have notbeen shown or described in detail to avoid unnecessarily obscuringdescriptions of the embodiments.

Unless the context requires otherwise, throughout the specification andclaims which follow, the word “comprise” and variations thereof, suchas, “comprises” and “comprising” are to be construed in an open,inclusive sense, that is as “including, but not limited to.”

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least oneembodiment. Thus, the appearances of the phrases “in one embodiment” or“in an embodiment” in various places throughout this specification arenot necessarily all referring to the same embodiment. Further more, theparticular features, structures, or characteristics may be combined inany suitable manner in one or more embodiments.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contentclearly dictates otherwise. It should also be noted that the term “or”is generally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

The headings and Abstract of the Disclosure provided herein are forconvenience only and do not interpret the scope or meaning of theembodiments.

This disclosure describes various systems, methods and articles relatedto performing assays on various assay media. Many embodiments arecapable of providing actual quantitative analysis, providing uniformresults and reducing errors. Many embodiments are capable of handlingmultiple pieces of assay media, which may advantageously increasethroughput. Many embodiments are capable of handling assay media withoutcumbersome carriers, such as cartridges, frames or holders. Manyembodiments are capable of handling assay media of different formats,for example assay media from different manufacturers or differentproduct lines of a given manufacturer. Many embodiments are capable ofproviding an intuitive graphical user interface, which can lead a userthrough the various steps associated with performing a given assay. Suchmay be based on a given configuration, which may in turn be based on agiven type of assay medium or assay being performed. Such may also beeasily reconfigurable, allowing a single assay system to handle manydifferent types of assays, and reducing the need for highly skilledpersonnel. These and other advantages may be realized via the variousembodiments described herein.

FIG. 1 shows an assay system 100 according to one illustratedembodiment.

The assay system 100 includes an assay device 102 configured to performassays or assay evaluations on assay strips. The assay device 102 mayinclude a housing 104 including one or more slots 106 (only one calledout in FIG. 1) sized to receive at least one assay strip therein. Theassay strips may advantageously be received directly in the slots,without the need from cartridges, receivers, frames, holders or othercumbersome assay strip carrier structures. The slots 106 provide accessto an interior of the housing 104. Each of the slots 106 may beidentified or labeled with a respective machine-readable symbol 108(only one called out in FIG. 1) which allows automatic identification ofthe slot 106 via machine reading. Such machine-readable symbols 108 maytake the form of barcode symbols, matrix or area code symbols, orstacked code symbols. The assay device 102 may further include one ormore displays 110 on which instructions, data, information and or aportion of a user interface (e.g., user selectable icons, pull-downmenus, dialog boxes, fields, etc.) may be selectively displayed. Theassay device 102 may include one or more user input devices, forexample, a scan start button 112 a and a scan stop button 112 b. Thescan start and stop buttons 112 a, 112 b may be used to start and stopscans when not under automatic control or under control from thegraphical user interface.

The assay system 100 may also include one or more peripheral computingsystems 114 communicatively coupled to the assay device 102. Thecomputing system 114 may take a variety of forms including desktop orlaptop personal computers, workstations, mini computers, mainframecomputers, server or client computers. The computing system 114 mayinclude a user input subsystem 116 which may include a display 118,keyboard or keypad 120, pointing device such as track pad 122, joystick,trackball, etc., as well as user-selectable icons. The computing system114 may be communicatively coupled to the assay device 102 via a wiredor wireless connection, which may, for example take the form of a localarea network (LAN) or wide area network (WAN).

The assay system 100 may optionally include a stand-alone reader 130communicatively coupled to the assay device 102 and/or peripheralcomputing system 114. The reader 130 may take a variety of formsincluding a scanner employing focus light or an imager employing floodillumination or ambient light. The reader 130 may take the form of anycommercially available machine-readable symbol reader such as thoseavailable from Intermec Technologies of Everett, Wash. Themachine-readable symbol reader may be configured to readmachine-readable symbols encoded in one or more machine-readablesymbologies (e.g., Code 93i, Code 39, Datamatrix code, UPC/EAN, etc.).The assay system 100 may employ other automatic data collection devicesas readers, for example magnetic stripe readers, radio frequencyidentification readers or interrogators, etc.

FIG. 2 and the following discussion provide a brief, general descriptionof a suitable assay system environment 200 in which the variousillustrated embodiments can be implemented. Although not required, theembodiments will be described in the general context ofcomputer-executable instructions, such as program application modules,objects, or macros stored on computer- or processor readable-media andexecuted by a computer or processor. Those skilled in the relevant artwill appreciate that the illustrated embodiments as well as otherembodiments can be practiced with other assay system configurationsand/or other computing system configurations, including hand-helddevices, multiprocessor systems, microprocessor-based or programmableconsumer electronics, personal computers (“PCs”), network PCs, minicomputers, mainframe computers, and the like. The embodiments can bepracticed in distributed computing environments where tasks or modulesare performed by remote processing devices, which are linked through acommunications network. In a distributed computing environment, programmodules may be located in both local and remote memory storage devices.

FIG. 2 shows an assay system environment 200 comprising one or moreassay devices 102, peripheral computing systems 114, readers 130 andoptionally one or more server computing systems 206 coupled by one ormore communications channels, for example one or more local areanetworks (LANs) 208 or wide area networks (WANs) 210. The assay system200 may employ other computers, such as conventional personal computers,where the size or scale of the system allows.

The assay device 102 may include one or more processing units 212 a, 212b (collectively 212), system memory 214 and a system bus 216 thatcouples various system components including the system memory 214 to theprocessing units 212. The assay device 102 will at times be referred toin the singular herein, but this is not intended to limit theembodiments to a single assay device since in typical embodiments, theremay be more than one assay device or other device involved. Theprocessing units 212 may be any logic processing unit, such as one ormore central processing units (CPUs) 212 a, digital signal processors(DSPs) 212 b, application-specific integrated circuits (ASICs), fieldprogrammable gate arrays (FPGAs), etc. Unless described otherwise, theconstruction and operation of the various blocks shown in FIG. 2 are ofconventional design. As a result, such blocks need not be described infurther detail herein, as they will be understood by those skilled inthe relevant art.

The system bus 216 can employ any known bus structures or architectures,including a memory bus with memory controller, a peripheral bus, and alocal bus. The system memory 214 includes read-only memory (“ROM”) 218and random access memory (“RAM”) 220. A basic input/output system(“BIOS”) 222, which can form part of the ROM 218, contains basicroutines that help transfer information between elements within theassay device 102, such as during start-up.

The assay device 102 may include a hard disk drive 224 for reading fromand writing to a hard disk 226, optical disk drive 228 for reading fromand writing to removable optical disks 232, and/or a magnetic disk drive230 for reading from and writing to magnetic disks 234. The optical disk232 can be a CD-ROM, while the magnetic disk 234 can be a magneticfloppy disk or diskette. The hard disk drive 224, optical disk drive 228and magnetic disk drive 230 may communicate with the processing unit 212via the system bus 216. The hard disk drive 224, optical disk drive 228and magnetic disk drive 230 may include interfaces or controllers (notshown) coupled between such drives and the system bus 216, as is knownby those skilled in the relevant art. The drives 224, 228 and 230, andtheir associated computer-readable media 226, 232, 234, providenonvolatile storage of computer readable instructions, data structures,program modules and other data for the assay device 102. Although thedepicted assay device 102 is illustrated employing a hard disk 224,optical disk 228 and magnetic disk 230, those skilled in the relevantart will appreciate that other types of computer-readable media that canstore data accessible by a computer may be employed, such as magneticcassettes, flash memory cards, digital video disks (“DVD”), Bernoullicartridges, RAMs, ROMs, smart cards, etc.

Program modules can be stored in the system memory 214, such as anoperating system 236, one or more application programs 238, otherprograms or modules 240 and program data 242. Program modules mayinclude instructions for handling security such as password or otheraccess protection and communications encryption. The system memory 214may also include communications programs for example a Web client orbrowser 244 for permitting the assay device 102 to access and exchangedata with sources such as Web sites of the Internet, corporateintranets, extranets, or other networks as described below, as well asother server applications on server computing systems such as thosediscussed further below. The browser 244 in the depicted embodiment ismarkup language based, such as Hypertext Markup Language (HTML),Extensible Markup Language (XML) or Wireless Markup Language (WML), andoperates with markup languages that use syntactically delimitedcharacters added to the data of a document to represent the structure ofthe document. A number of Web clients or browsers are commerciallyavailable such as those from America Online and Microsoft of Redmond,Wash.

While shown in FIG. 2 as being stored in the system memory 214, theoperating system 236, application programs 238, other programs/modules240, program data 242 and browser 244 can be stored on the hard disk 226of the hard disk drive 224, the optical disk 232 of the optical diskdrive 228 and/or the magnetic disk 234 of the magnetic disk drive 230.

An operator can enter commands and information into the assay device 102through input devices such as a touch screen or keyboard 246 and/or apointing device such as a mouse 248 and graphical user interface. Otherinput devices can include a microphone, joystick, game pad, tablet,scanner, etc. These and other input devices are connected to one or moreof the processing units 212 through an interface 250 such as a serialport interface that couples to the system bus 216, although otherinterfaces such as a parallel port, a game port or a wireless interfaceor a universal serial bus (“USB”) can be used. A monitor 252 or otherdisplay device is coupled to the system bus 216 via a video interface254, such as a video adapter. The assay device 102 can include otheroutput devices, such as speakers, printers, etc.

The assay device 102 includes one or more imagers 266, operable tocapture high resolution images of assay strips received when received inthe slots 106 (FIG. 1) of the assay device. The imager 266 may take avariety of forms, for example one- or two-dimensional arrays of chargedcoupled devices, CMOS sensors, digital still cameras, digital videocameras, analog video cameras with frame grabbers, etc. For example, theimager 266 may include an illumination source to illuminate the assaystrips. The illumination source may, for example, take the form of oneor more lamps, for instance one or more fluorescent lamps which mayadvantageously eliminate or reduce the need for hardware filters orsoftware filters. Various specific embodiments of imagers 266 arediscuss below with reference to FIGS. 3-5. A buffer (not shown) maybuffer data from the imager 266 until the DSP 212 b is ready to processthe image data.

The assay device 102 can operate in a networked environment usinglogical connections to one or more remote computers and/or devices, forexample the server computing system 206. The server computing system 206can be another personal computer, a server, another type of computer, ora collection of more than one computer communicatively linked togetherand typically includes many or all of the elements described above forthe assay device 102. The server computing system 206 is logicallyconnected to one or more of the assay devices 102 under any known methodof permitting computers to communicate, such as through one or more LANs208 and/or WANs 210 such as the Internet. Such networking environmentsare well known in wired and wireless enterprise-wide computer networks,intranets, extranets, and the Internet. Other embodiments include othertypes of communication networks including telecommunications networks,cellular networks, paging networks, and other mobile networks.

When used in a LAN networking environment, the assay device 102 isconnected to the LAN 208 through an adapter or network interface 260(communicatively linked to the system bus 216). When used in a WANnetworking environment, the assay device 102 may include a modem 262 orother device, such as the network interface 260, for establishingcommunications over the WAN 210. The modem 262 is shown in FIG. 2 ascommunicatively linked between the interface 250 and the WAN 210. In anetworked environment, program modules, application programs, or data,or portions thereof, can be stored in the server computing system 206.In the depicted embodiment, the assay device 102 is communicativelylinked to the server computing system 206 through the LANs 208 and/orWAN 210, for example with TCP/IP middle layer network protocols.However, other similar network protocol layers are used in otherembodiments, such as User Datagram Protocol (“UDP”). Those skilled inthe relevant art will readily recognize that the network connectionsshown in FIG. 2 are only some examples of establishing communicationlinks between computers, and other links may be used, including wirelesslinks.

The server computing system 206 is also communicatively linked to one ormore other computing systems or devices, such as the peripheralcomputing system 114 and/or reader 130, typically through the LAN 208 orthe WAN 210 or other networking configuration such as a directasynchronous connection (not shown).

The server computing system 206 includes server applications 264 for therouting of instructions, programs, data and agents between the assaydevice 102, peripheral computing system 114 and/or reader 130. Forexample the server applications 264 may include conventional serverapplications such as WINDOWS NT 4.0 Server, and/or WINDOWS 2000 Server,available from Microsoft Corporation or Redmond, Wash. Additionally, oralternatively, the server applications 264 can include any of a numberof commercially available Web servers, such as INTERNET INFORMATIONSERVICE from Microsoft Corporation and/or IPLANET from Netscape.

The peripheral computing system 114 may take the form of a conventionalmainframe computer, mini-computer, workstation computer, personalcomputer (desktop or laptop), or handheld computer. The computing system114 may include a processing unit 268, a system memory 269 and a systembus (not shown) that couples various system components including thesystem memory 269 to the processing unit 268. The peripheral computingsystem 114 will at times be referred to in the singular herein, but thisis not intended to limit the embodiments to a single peripheralcomputing system 114 since in typical embodiments, there may be morethan one peripheral computing system 114 or other device involved.Non-limiting examples of commercially available systems include, but arenot limited to, an 80×86 or Pentium series microprocessor from IntelCorporation, U.S.A., a PowerPC microprocessor from IBM, a Sparcmicroprocessor from Sun Microsystems, Inc., a PA-RISC seriesmicroprocessor from Hewlett-Packard Company, or a 68xxx seriesmicroprocessor from Motorola Corporation.

The processing unit 268 may be any logic processing unit, such as one ormore central processing units (CPUs), digital signal processors (DSPs),application-specific integrated circuits (ASICs), field programmablegate arrays (FPGAs), etc. Unless described otherwise, the constructionand operation of the various blocks of the peripheral computing system114 shown in FIG. 2 are of conventional design. As a result, such blocksneed not be described in further detail herein, as they will beunderstood by those skilled in the relevant art.

The system bus can employ any known bus structures or architectures,including a memory bus with memory controller, a peripheral bus, and alocal bus. The system memory 269 includes read-only memory (“ROM”) 270and random access memory (“RAM”) 272. A basic input/output system(“BIOS”) 271, which can form part of the ROM 270, contains basicroutines that help transfer information between elements within theperipheral computing system 114, such as during start-up.

The peripheral computing system 114 also includes one or more mediadrives 273 (e.g., a hard disk drive, magnetic disk drive, and/or opticaldisk drive) for reading from and writing to computer-readable storagemedia 274 (e.g., hard disk, optical disks, and/or magnetic disks). Thecomputer-readable storage media 274 may, for example, take the form ofremovable media. For example, hard disks may take the form of aWinchester drives, optical disks can take the form of CD-ROMs, whilemagnetic disks can take the form of magnetic floppy disks or diskettes.The media drive(s) 273 communicate with the processing unit 268 via oneor more system buses. The media drives 273 may include interfaces orcontrollers (not shown) coupled between such drives and the system bus,as is known by those skilled in the relevant art. The media drives 273,and their associated computer-readable storage media 274, providenonvolatile storage of computer readable instructions, data structures,program modules and other data for the peripheral computing system 114.Although described as employing computer-readable storage media 274 suchas hard disks, optical disks and magnetic disks, those skilled in therelevant art will appreciate that peripheral computing system 114 mayemploy other types of computer-readable storage media that can storedata accessible by a computer may be employed, such as magneticcassettes, flash memory cards, digital video disks (“DVD”), Bernoullicartridges, RAMs, ROMs, smart cards, etc. Data or information, forexample, high resolution images or image data, identificationinformation, results of assays, etc., can be stored in thecomputer-readable storage media 274.

Program modules, such as an operating system, one or more applicationprograms, other programs or modules and program data, can be stored inthe system memory 269. Program may include instructions for handlingsecurity such as password or other access protection and communicationsencryption. The system memory 269 may also include communicationsprograms for example a Web client or browser that permits the peripheralcomputing system 114 to access and exchange data with sources such asWeb sites of the Internet, corporate intranets, extranets, or othernetworks as described below, as well as other server applications onserver computing systems such as those discussed further below. Thebrowser may, for example be markup language based, such as HypertextMarkup Language (HTML), Extensible Markup Language (XML) or WirelessMarkup Language (WML), and may operate with markup languages that usesyntactically delimited characters added to the data of a document torepresent the structure of the document.

While described as being stored in the system memory 269, the operatingsystem, application programs, other programs/modules, program dataand/or browser can be stored on the computer-readable storage media 274of the media drive(s) 273. An operator can enter commands andinformation into the peripheral computing system 114 via a userinterface 275 through input devices such as a touch screen or keyboard276 and/or a pointing device 277 such as a mouse. Other input devicescan include a microphone, joystick, game pad, tablet, scanner, etc.These and other input devices are connected to the processing unit 269through an interface such as a serial port interface that couples to thesystem bus, although other interfaces such as a parallel port, a gameport or a wireless interface or a universal serial bus (“USB”) can beused. A display or monitor 278 may be coupled to the system bus via avideo interface, such as a video adapter. The peripheral computingsystem 114 can include other output devices, such as speakers, printers,etc.

The peripheral computing system 114 can operate in a networkedenvironment using logical connections to one or more remote computersand/or devices, for example the server computing system 206.

The reader 130 may include one or more components operable to readmachine-readable information carried by various articles.

The reader 130 may take the form of a machine-readable symbol readerconfigured to optically (e.g., visible, infrared, ultravioletwavelengths of electromagnetic energy) read information encoded inmachine-readable symbols (e.g., barcode symbols, stacked code symbols,area or matrix code symbols) carried by various articles. In such anembodiment, the reader 130 includes an information acquisition componentor engine 280 to optically acquire the machine-readable symbol. Suchmay, for example, take the form of a scan engine that scansmachine-readable symbols using a narrow beam of light (e.g., laserscanner). Alternatively, such may take the form of an image based readerthat acquires images using floodlighting or ambient light. The reader130 may be capable of capturing an image of a larger area encompassing anumber of assay strips (e.g., eight strips). This can advantageouslyallow higher throughput as compared to conventional systems.

The reader 130 may also include a processor subsystem 282 configured topreprocess or process the optically acquire information. For instance,the processor subsystem 282 may be configured to decode informationencoded in the machine-readable symbol, and may even determine whichsymbology to use in decoding machine-readable symbols encoded using avariety of different machine-readable symbologies (Code 39, Code 93i,DataMatrix, UPC/EAN). The processor subsystem 282 may include one ormore processors (e.g., microprocessors, DSPs, ASICs, FPGAs), and memory(spinning media or solid-state media such as RAM, ROM, and FLASH media).The processor subsystem 282 may be an integral component of the reader130 or may be a distinct dedicated component. Alternatively, theprocessing may be handled by another component, for instance theperipheral computing system 114 or assay device 102. A variety ofsuitable machine-readable symbol readers are commercially available, forexample, from Intermec Technologies and Symbol Technologies.

The reader 130 may take the form of one or more magnetic stripe readersoperable to information magnetically encoded in one or more magneticstripes carried by various articles. In such an embodiment, the reader130 includes an information acquisition component or engine 280 tomagnetically acquired information encoded in the magnetic stripe.

Such an embodiment may also include a processor subsystem 282 configuredto preprocess or process the magnetically acquired information. Forinstance, the processor subsystem 282 may be configured to decodeinformation encoded in the magnetic stripe, and may even decodeinformation encoded using a variety of specifications or formats. Theprocessor subsystem 282 may include one or more processors (e.g.,microprocessors, DSPs, ASICs, FPGAs), and memory (spinning media orsolid-state media such as RAM, ROM, FLASH). The processor subsystem 282may be an integral component of the reader 130 or may be a distinctdedicated component. Alternatively, the processing may be handled byanother component, for instance the peripheral computing system 114 orassay device 102. Suitable magnetic stripe readers are commerciallyavailable from a variety of sources.

The reader 130 may take the form of one or more RFID readers orinterrogators operable to wirelessly read information encoded into oneor more RFID transponder (e.g., tags). In such an embodiment, the reader1230 includes an information acquisition component or engine 208 towirelessly (e.g., RF or microwave wavelengths of electromagnetic energy)interrogate an RFID transponder and to receive information encoded in aresponse from the RFID transponder.

Such an embodiment may also include a processor subsystem 282 configuredto preprocess or process the wirelessly acquired information. Forinstance, the processor subsystem 282 may be configured to decodeinformation encoded in the RFID transponder's response, and may evendecode information encoded using a variety of specifications or formats.The processor subsystem 282 may include one or more processors (e.g.,microprocessors, DSPs, ASICs, FPGAs), and memory (spinning media orsolid-state media such as RAM, ROM, FLASH). The processor subsystem 282may be an integral component of the reader 130 or may be a distinctdedicated component. Alternatively, the processing may be handled byanother component, for instance the peripheral computing system 114 orassay device 102. Suitable RFID interrogators or readers arecommercially available from a variety of sources including SymbolTechnologies and Intermec Technologies.

The reader 130 may be used to read machine-readable information carriedby assay strips, test tubes, cuvettes, cups, plates, wells, trays, orcarried on the assay device (e.g., machine-readable symbols 108 markingrespective slots 106, illustrated in FIG. 1). The machine-readableinformation may be carried by a tag or label which is adhered orotherwise attached to the article. Alternatively, the machine-readableinformation may be printed, engraved, etched, or otherwise applied tothe article itself, without the use of a tag or label. Themachine-readable information may include unique identificationinformation (e.g., alphanumeric serial number, etc.), which uniquelyidentifies the article.

FIG. 3 shows a number of assay strips 300 a-300 h (collectively 300)positioned relative to an imager 302 to capture high resolution imagesof the assay strips 300, according to one illustrated embodiment. Theassay strips 300 may include a positive test result signal line 304(only one called out in FIG. 3) and a control signal line 306 (only onecalled out in FIG. 3). The positive test result signal line 304 providesa visible indication of the presence of an analyte or some othersubstance. The control signal line 306 provides a visible indicationthat the assay strip 300 is functioning correctly. The assay strip 300may also include one or more machine-readable symbols 308 (only onecalled out in FIG. 3) which may encode identification information thatuniquely identifies the assay strip 300 over some large set of assaystrips. The machine-readable symbol 308 may, for example, take the formof a barcode symbol. Alternatively, other structures to associateidentification information with the assay strip 300 may be employed, forexample, RFID tags or magnetic stripes.

The imager 302 may take the form of a two-dimensional image device, forinstance, a two-dimensional array of charge coupled devices (CCDs) orCMOS devices. Consequently, the imager 302 may capture an image of anarea that is larger than an area of a single assay strip 300. Typically,the imager 302 captures a high resolution image of an area greater thantwo assay strips 300, for example eight assay strips 300.

FIG. 4 shows a plurality of assay strips 400 a-400 h (collectively 400)positioned to be imaged by an imager 402 according to anotherillustrated embodiment. The assay strips 400 include a positive resultsignal line 404 (only one called out in FIG. 4), a control signal line406 (only one called out in FIG. 4) and a unique identifier 408. Theimager 402 may take the form of a one-dimensional image capture device,for example, a one-dimensional array of CCDs. The imager 402 is mountedfor movement relative to the assay strips 400. For example, the imager402 may be mounted for translation along rails 410 a, 410 b.Alternatively, the imager 402 may be mounted for rotation or pivotingwith respect to the assay strips 400. A drive system 412 may be coupledto move the imager 402 relative to the assay strips 400. The drivesystem 412 may include one or more actuators, for example, a motor 414which in some embodiments may take the form of a stepper motor. Themotor 414 may be coupled to one or more processors 212 (FIG. 2) toreceive drive signals therefrom. The motor 414 may drive one or morelinkages, for example, a belt 416 and pulley 418 to cause movement ofthe imager 402 to image an area larger than a single assay strip 400,for example an area occupied by eight assay strips. Other drivemechanisms may be employed.

FIG. 5 shows a plurality of assay strips 500 a-500 h (collectively 500)positioned to be read by imagers 502 a, 502 b (collectively 500),according to another illustrated embodiment. As noted before, the assaystrips 500 include a positive result signal line 504 (only one calledout in FIG. 5), a control signal line 506 (only one called out in FIG.5) and a machine-readable identifier 508 (only one called out in FIG.5). The imagers 502 a, 502 b may take a variety of forms including one-or two-dimensional arrays of charge-coupled devices, or CMOS imagesensors. One or more mirrors or prisms 510 a-510 d (collectively 510)may be positioned to reflect or refract an image of the assay strips 500toward the imager devices 502 as illustrated by image paths 512 a, 512 b(collectively 512). One or more lenses 514 a, 514 b (collectively 514)may be interposed in the image paths 512 to focus the images of theassay strips 500 onto the image devices 502. The lenses 514 may take avariety of forms including optical lenses of glass, acrylic or plastic,adjustable lenses including mechanically adjustable lenses or fluidlenses. The lenses 514 may, for example, take the form of cylindricallenses. One or more mechanical apertures may also be employed. Theimagers 502 are capable of imaging an area greater than an area of asingle assay strip, for example an array that encompasses eight assaystrips.

The various imagers discussed above can take a variety of forms. Forexample, the imagers may be CCDs or CMOS based, may be one- ortwo-dimensional arrays, may be black and white, gray-scale or colordevices, may be digital still cameras, digital video cameras, analogstill cameras, analog video cameras, board imagers, etc. Imagers mayinclude frame grabbers, may couple to frame grabbers and may operatewithout the need for a frame grabber. Suitable imagers are commerciallyavailable in a large variety of forms from a large variety of suppliers.

FIG. 6 shows a method 600 of operating an assay system according to oneillustrated embodiment.

At 602, assay strips are received in an interior of the housing of anassay device, for example, via one or more slots. The assay strips mayadvantageously be received directly in the slots, without the need for acartridge, frame, receiver, holder or other cumbersome assay stripcarrier. Alternatively, the assay device may include a cover which ismoveable between an open position in which access to the interior isprovided and a closed position in which access to the interior isblocked. In the closed position, the cover may provide a barrier toambient light, controlling the internal environment to enhance imagecapture or acquisition. The cover may, for example, be pivoted betweenthe open and closed positions, similar to that commonly used in flat bedscanners.

At 604, one or more imagers captures a high resolution image of at leasta portion of the assay strips received in the housing. The imager(s) maycapture or otherwise acquire an image of an area larger than an area ofa single assay strip. For example, the imager(s) may capture a highresolution image of an area that encompasses multiple assay strips, forinstance eight assay strips. The imager(s) may take the form of a flatbed imager. The number of assay strips may not be known to the assaydevice before the high resolution image is captured, so long as an imageof a sufficiently large area is captured or otherwise acquired.

At 606, a processor computationally identifies individual assay stripsin the high resolution image. The processor may employ a variety ofmachine-vision or image processing techniques to identify individualassay strips in the high resolution image. In some embodiments, theprocessor may employ approximate positions in the image to locate theindividual assay strips, for example where the slots cause the assaystrips to be positioned in relatively fixed locations with respect tothe imager(s). In other embodiments, the processor identifies the assaystrips in the image without any reference to approximate positions. Thismay be particularly useful where the imager is a flat bed scanner, andassay strips may be positioned at widely divergent positions betweensuccessive runs.

At 608, the processing system computationally performs an objectiveassay evaluation for each assay strip based on a representation of oneor more signal lines (e.g., positive test results, control) in thecaptured high resolution image. For example, the processing system maydetermine a magnitude of a positive test results signal line and comparethe determined magnitude to a threshold value. Also for example, theprocessing system may determine whether a control signal line ispresent, indicating a positive result only where the control signal lineis present and the magnitude of the positive test result signal lineexceeds the threshold value. The presence of a control signal linetypically indicates that the test has been completed successfully,thereby validating the result. Given a positive control signal line, theabsence of a test signal line indicates a negative result. Given apositive control signal line, the presence of a test signal lineindicates a positive result. The processing system may subtract out oneor more background colors and/or perform other image processing toenhance or produce uniform results.

FIG. 7 shows a method 700 of receiving assay strips, according to oneillustrated embodiment.

At 702, a plurality of assay strips are received in the interior of thehousing arranged to expose a portion of each of the assay strips to theimager. Such allows the imager to capture high resolution images of atleast a portion of each of the assay strips. While each assay strip maybe fully exposed to the imager(s), some embodiments may expose only alongitudinal portion of each assay strip (e.g., assay strips in a columnpartially overlap one another) so long as a sufficient portion of eachassay strip is exposed to perform the analysis. Such may allow areduction in form factor for the assay device, for example allowproduction of a handheld device capable of analyzing multiple assaystrips in a single run. As previously noted, the assay strips may bereceived via one or more slots, or may be received when a cover is in anopen position, for instance laid out on an at least partiallytransparent plate (e.g., glass or acrylic).

FIG. 8 shows a method 800 of capturing high resolution images, accordingto one illustrated embodiment.

At 802, one or more imagers captures a high resolution image of an areawith a dimension greater than the dimension of a single assay strip.Thus, for example, the imager may capture an image of two or more assaystrips simultaneously or concurrently, for instance an area encompassingeight assay strips. This may facilitate increased throughput, allowingmultiple assay strips to be processed in a single run.

FIG. 9 shows a method 900 of capturing high resolution images accordingto another illustrated embodiment.

At 902, the imager(s) captures an image of an area with a length andwidth that is greater than a length and width of at least two adjacentassay strips. Thus, for example, the imager(s) may capture an imagecontaining portions of two or more assay strips simultaneously orconcurrently, for instance an area encompassing eight assay strips. Thismay facilitate increased throughput, allowing multiple assay strips tobe processed in a single run.

FIG. 10A shows a method 1000 of operating an assay device according toone illustrated embodiment, including computationally identifyingindividual assay strips in an acquired high resolution image. The method1000 may determine actual color distribution of test results and controlsignal lines, using red, green, blue (i.e., RGB) ratios or other colorratios, which may advantageously facilitate analysis.

At 1002, at least one processor initiates a request to an imager toacquire an image, and waits for the image to become available. Thecurrent implementation uses TWAIN to communicate with an Avision AVA6+scanner attached directly to a computer (e.g., assay device 102 orcomputing system 114 of FIG. 1) executing a set of BACSTAT™ softwareinstructions.

At 1004, the processor(s) processes the acquired image for identifiers.For example, the processor may invoke a third-party software library tosearch the image for identifier symbols, for example barcode symbols.Thus, the processor(s) may identify any machine-readable symbols in theacquired high resolution image. The processor(s) stores the location andcontents of all identifiers (e.g., barcode symbols) located in theacquired image.

The processor(s) then searches the acquired image for test strips,without relying on prior knowledge of how many assay strips might bepresent in the image or where the assay strips might be found in theimage. The processor(s) may perform such using the sub-procedure set outas 1006.

At 1006, the processor(s) performs a first iteration of pixeltransformation (i.e., Image Processing I) based on a first color. Inparticular, a second copy of the acquired image may be made in a memory,in which pixels falling within a particular range of “blue” colors(based on hue and saturation) are identified, and all other pixels arechanged to black. The processor(s) may apply standard “erode” and“dilate” filters to reduce noise.

At 1008, the processor(s) performs a first iteration of blob analysis(i.e., Blob Analysis I). In particular, the processor(s) identifyconnected groups (“blobs”) of non-black pixels. A bounding rectangle isrecorded for each blob, as well as a “weight” value indicating thenumber of non-black pixels making up the blob.

At 1010, the processor(s) performs symbol compensation (i.e., BarcodeCompensation). In particular, the processor(s) identifies pairs of blobswhere the weight of each blob is within a particular range, the blobs'bounding rectangles overlap in the horizontal dimension, and thevertical distance between the blobs' centers is within a particularrange. The processor(s) remove the blobs from the set and replaces theblobs with a single, larger, synthesized blob whose bounding rectangleis the smallest rectangle enclosing both smaller blobs, and whose weightis the sum of the smaller blobs' weights plus the area in between thetwo smaller blobs. The processor(s) calculates the latter area bymultiplying the distance between the upper blob's lower bound and thelower blob's upper bound by the mean of the two blobs' widths.

At 1012, the processor(s) performs a first iteration of blob pairing isperformed (i.e., Blob Pairing I) on blobs resulting from the firstduration of blob analysis. In particular, the processor(s) identifiespairs of related blobs where the weight of one blob is greater than aparticular threshold, the ratio of weights between the two blobs fallswithin a particular range, the blobs' bounding rectangles overlap in thehorizontal dimension, and the vertical distance between the blobs'centers is below a particular threshold. When a pair is identified, itis recorded and the component blobs are excluded from further pairing.The processor(s) repeats such until all such pairs have been found.

At 1014, the processor(s) performs a second iteration of pixeltransformation based on a second color (i.e., Image Processing II). Inparticular, the processor(s) makes a third copy of the image, in whichpixels falling within a particular range of “white” colors (based onsaturation and brightness) are identified, and all other pixels arechanged to black. The processor(s) may apply standard “erode” and“dilate” filters to reduce noise.

At 1016, the processor(s) performs a second iteration of blob analysison the results from the second iteration of pixel transformation (i.e.,Blob Analysis II). In particular, the processor(s) identify connectedgroups of non-black pixels, in a fashion similar to that described at1008.

At 1018, the processor(s) perform a second iteration of blob pairing onblobs resulting from the second iteration of blob analysis (referred toas Blob Pairing II). In particular, the processor(s) identifies pairs ofrelated blobs in a fashion similar to that at 1012 but using a differentweight threshold and range. After each pair is identified, theprocessor(s) attempts to match the pair against one of the “blue” pairsthat was identified earlier at 1012. A potential match is accepted whenall four blobs overlap in the horizontal dimension, the smaller whiteblob is above the larger blue blob, the larger blue blob is above thelarger white blob, and the larger white blob is above the smaller blueblob.

While not illustrated, the processor(s) may perform any number ofadditional iterations of pixel transformation based on additional colorsand/or blob analysis on the results of the additional iterations ofpixel transformation. Such additional iterations may advantageously beemployed to identify different or multiple assay types. Thus, theprocessor(s) may be configured by an end user to run a variable numberof iterations and can match a variable number of blobs in eachiteration, for example, based on a template customized for each newassay type. The template may take the form of a data file, which can besupplied with the system software or supplied after the sale of thesystem or even after some use of the system. Such allows aftermarketconfiguration of the system to accommodate newly introduced assay typesor to accommodate a change to an existing assay type that an end usermay not have previously been interested in using.

At 1020, the processor(s) identifies the individual assay stripsappearing in the acquired image. In particular, the processor(s)identify each accepted match as a respective assay strip. With eachassay strip are associated the bounding rectangles of the four blobsthat compose the assay strip, a whole-strip bounding rectangle (i.e.,the smallest rectangle enclosing all four blobs), and, if any of theidentification (e.g., barcode) symbols found at 1004 intersect thewhole-strip bounding rectangle, the contents of the first suchidentification (e.g., barcode) symbol.

At 1022, the processor(s) objectively quantify at least one positiveresults signal line represented in the high resolution image. At 1024,the processor(s) evaluate at least one control signal line representedin the high resolution image. In quantifying the positive results signalline and/or evaluating control signal line, the processor(s) may analyzethe section of the acquired image residing inside the bounding rectangleof the larger white blob associated with each test strip (i.e., the“window”). The performing 1022 and 1024, the processor(s) may employ amethod 1030 (FIG. 10B).

At 1026, the processor(s) may decode identification information encodedin the identified machine-readable symbols. At 1028, the processor(s)may logically associate the decoded identification information with therespective assay strip.

At 1030, the processor(s) displays a results screen with informationabout each test strip. The information may include the test linedensity, the assessment (e.g., Positive, Negative, Blank), and a highresolution image of the assay strip.

At 1032, the processor(s) store results for each assay strip in adatabase on a computer-readable storage medium (e.g., hard disk, opticaldisk, floppy disk, FLASH card, etc.). Each record may include a fullhigh resolution image of the assay strip, the assessment, the currenttime, a flag indicating whether the user has acknowledged the result,and the name of the user who initiated the scan or assay. Each recordmay also contain various data entered by the user to identify the assaystrip and the sample that was tested. Information read from the symbols(e.g., barcode symbols) may be used to match each assay strip to thepreviously entered data.

At 1034, the processor(s) displays a screen that requires the user toacknowledge each test result, before proceeding to additional scans orassays.

FIG. 10B shows a method 1040 of objectively quantifying at least onepositive results signal line and/or evaluating at least one controlsignal line represented in the high resolution image, according to oneillustrated embodiment. The method 1030 may be employed in performing1022 and/or 1024 of the method 1000 (FIG. 10A).

At 1042, the processor(s) adaptively narrows the window to eliminateshadows at the edges. For example, the processor(s) may employ a method1070 (FIG. 10C).

At 1044, the processor(s) determine an “enhanced average” value for eachrow of pixels in the window. This is defined as the mean brightness forrows where the difference between the darkest pixel and the meanbrightness is below a particular threshold, and as the brightness of thebrightest pixel for the other rows.

At 1046, the processor(s) scales and inverts the enhanced averagevalues, producing a data set that can be visualized as a graph (i.e.,the “signal graph”) 1090 (FIG. 10D) whose peaks indicate darker rows inthe image.

At 1048, the processor(s) locates the “control window” 1092 on thesignal graph. For example, the processor(s) may search for the highestpeak within a particular range of rows and centering a fixed-size window1092 on the peak. This peak is denominated “CP” (FIG. 10D).

At 1050, the processor(s) averages a data point at the beginning of thewindow 1092 with the four surrounding data points, to obtain a pointdenominated “C1” (FIG. 10D). At 1052, the processor(s) averages a datapoint at the end of the window 1092 with the four surrounding datapoints to obtain a point denominated “C2” (FIG. 10D).

At 1054, the processor(s) determines the “control background line” 1094which is a line connecting C1 and C2 on the graph 1090 (FIG. 10D). At1056, the processor(s) determines an area of the graph 1090 within thecontrol window 1092 that is above the control background line 1094,which area is denominated as “F” (FIG. 10D). At 1056, the processor(s)also determines an area of the graph within the control window 1092 thatis below the control background line 1094, which area is denominated as“G” (FIG. 10D). A point at which the control background line 1094intersects a vertical line drawn through CP is denominated “CB” (FIG.10D).

At 1058, the processor(s) locates a “test window” 1096 on the signalgraph 1090 (FIG. 10D). For example, the processor(s) may place afixed-size window 1096 at a particular constant distance D1, D2 awayfrom the control window 1092. The highest peak within the test window islocated, denominated “TP” (FIG. 10D). Data points at the beginning andend of the test window 1096 are denominated “T1” and “H2” (FIG. 10D),respectively.

At 1060, the processor(s) determines a “test background line” 1098, theline connecting T1 and H2 on the graph 1090 (FIG. 10D). At 1062, theprocessor(s) determines an area of the graph within the test window 1096that is above the test background line 1098, which area is denominated“A” (FIG. 10D). At 1062, the processor(s) also determines an area of thegraph within the test window 1096 that is below the test background line1098, which area is denominated “B” (FIG. 10D). A point at which thetest background line 1098 intersects a vertical line drawn through TP isdenominated “TB” (FIG. 10D).

At 1064, the processor(s) combine the values obtained at 1048-1062 toproduce “control line density” and “test line density” values. Thecurrent implementation subtracts CB from CP to obtain the control linedensity, and subtracts TB from TP to obtain the test line density,although other calculations may be employed.

At 1066, the processor(s) determines whether the control and testresults signal lines are present on the assay strip in the acquiredimage. For example, the processor(s) may compare control and test linedensities against thresholds (e.g., factory-calibrated thresholds). Suchresults in a categorical assessment of the assay strip. For example, ifboth the control and test results signal lines are determined to bepresent, the assay strip is deemed “Positive”. If the control signalline is present but the test results signal line is absent, the assaystrip is deemed “Negative”. If the control signal line is absent, theassay strip is deemed “Blank”.

FIG. 10C shows a method 1070 of adaptively narrowing a window toeliminate shadows at edges of the window, according to one illustratedembodiment. The method 1070 may be employed in performing 1042 of method1040 (FIG. 10B).

At 1072, the processor(s) determines a mean brightness of each column ofpixels.

At 1074, the processor(s) determines a baseline brightness value. Forexample, the processor(s) may average the mean brightness values of acentermost 10% of columns together, giving a baseline brightness value.

At 1076, the processor(s) determines if any column to the left of thecentermost 10% of columns has a mean brightness that differs from thebaseline brightness by at least 50% of the baseline brightness. If so,the processor(s) sets the left edge of the window to the column to theright of the rightmost such column.

At 1078, the processor(s) determine if any column to the right of thecentermost 10% of columns has a mean brightness that differs from thebaseline brightness by at least 50% of the baseline brightness. If so,the processor(s) sets the right edge of the window to the column to theleft of the leftmost such column.

At 1080, the processor(s) ignores any part of the image that fallsoutside the edges of the new window.

FIG. 10D shows a graph 1090 representing the interrelationship ofvarious parameters and variable values in performing an assay, accordingto one illustrated embodiment.

In particular, the graph 1090 shows the interrelationship of many of theparameter and variable values identified in the methods 1000, 1040, 1070(FIGS. 10A-100). For example, the areas F and G above and under thecontrol background line 1094, respectively. Also for example, the areasA and B above and below the test background line 1098, respectively. Anumber of user controlled parameters are also noted, includingparameters D1, D2 that set the distance of the test window 1096 from thecontrol window 1092 as well as the width of the test window 1096, theparameter W that sets the width of control window W, and the parameter Tthat may set the width of the test window T. FIG. 10D also sets out anumber of the geometric relationships that may be employed in themethods 1000, 1040, 1070 including: A, NF, (A+B)/(F−FG), A/(D2−D1), and(A/F)*(W/(D2−D1)), where the symbol “*” indicates multiplication, thesymbol “/” indicates division, the symbol “+” indicates addition and thesymbol “−” indicates subtraction.

FIG. 11 shows a method 1100 of operating an assay system according toone illustrated embodiment.

At 1102, an assay device receives user input indicative of one or morevalues of configurable criteria used to perform objective assayevaluation. The user input may be entered by a user via a user inputdevice (e.g., keyboard, keypad, pointer device, touch-screen, etc.). At1104, assay strips are received in an interior of a housing of the assaydevice. As previously noted assay strips may be received in respectiveslots, or may be placed under a cover.

At 1106, one or more imagers of the assay device capture high resolutionimages of the assay strips. As previously noted, the imager(s) may bestationary or may move relative to the assay strips. The imager may becapable of acquiring an image of an area encompassing multiple assaystrips.

At 1108, a processor computationally performs objective assay evaluationfor the assay strips based on representations of signal lines in thecaptured high resolution image and based on the received user input. Forexample, a processor may employ some of the techniques set out in FIGS.10A-10C.

FIG. 12 shows a method 1200 of receiving user input according to oneillustrated embodiment. At 1202, the assay device receives user inputindicative of a threshold level for objective assay evaluation. The userinput may be entered by a user via a user input device.

FIG. 13 shows a method 1300 of receiving user input according to anotherillustrated embodiment. At 1302, the assay device receives user inputindicative of a threshold intensity level for positive result signallines. The user input may be entered by a user via a user input device

FIG. 14 shows a method 1400 of receiving user input according to yetanother illustrated embodiment. At 1402, the assay device receives avalue indicative of a physical format of an assay strip. Such values maybe indicative of a size (e.g., length, width) of the assay strip or anumber and/or position of positive result lines and/or control lines onthe assay strip. The user input may be entered by a user via a userinput device

FIG. 15 shows a method 1500 of receiving user input according to yetanother illustrated embodiment. At 1502, the assay device receives avalue indicative of a type of assay strip. For example, the value may beindicative of a make and model of assay strip. The user input may beentered by a user via a user input device

FIG. 16 shows a method 1600 of receiving user input according to yet afurther illustrated embodiment.

At 1602, the assay device receives a value indicative of an assay stripmanufacturer. Such may be logically associated with one or morecharacteristics of the assay strip, for example, physical formatincluding overall dimensions, number and/or position of positive resultsignal lines, control signal lines, colors, intensity, and/or dimensionsof signal lines. The user input may be entered by a user via a userinput device or may be scanned or otherwise read using automatic datacollection equipment (e.g., machine-readable symbol reader, RFID readeror interrogator, magnetic stripe reader, etc.).

FIG. 17 is a screen print showing an introductory screen 1700 of aportion of a user interface of the assay device, according to oneillustrated embodiment. The introductory screen includes a useridentifier field 1702 into which an end user may enter a useridentifier, for example, via a keyboard. The introductory screen 1700also includes a password field 1704 into which an end user may enter apassword, for example, via a keyboard. The introductory screen 1700further includes a user-selectable login icon 1706 which a user mayselect, for example, via a pointer device or a touch on a touch-screen,to log into the assay device. In response to selection of theuser-selectable login icon 1706, a processor system of the assay devicemay evaluate whether the entered user identifier and password are validand correctly match one another. If validated, entry into the rest ofthe assay program is granted.

FIG. 18 shows a STEP 1 screen 1800 of the user interface of the assaydevice, according to one illustrated embodiment. The STEP 1 screen 1800includes an instruction dialog box 1802 which lists various acts orinstructions involved in a step 1 of the assay process. For example, theacts or instructions may include: A) entering a bacstat kit number, B)entering a number of samples to be tested, C) scanning platelet bag, D)collecting platelet sample, E) adding platelet sample to tube, F)scanning a tube, and G) repeating the scanning, collecting, adding andscanning for each sample. The STEP 1 screen 1800 includes a number ofscan bag fields 1804 (only one called out in FIG. 18) for displayingidentifiers read from a platelet bag, and a number of scan tube fields1806 (only one called out in FIG. 18) for entering or displayingidentifiers read from tubes. The STEP 1 screen 1800 may include a kitnumber field 1808 that displays the identifier of the kit (bacstat kitnumber). The STEP 1 screen 1800 may include a login identity field 1810that displays an identifier associated with the end user currentlylogged in. The STEP 1 screen 1800 includes a sample number field 1812that indicates the number of samples being assayed. The STEP 1 screen1800 also includes a user-selectable next step icon 1814. Selection ofthe next step icon 1814 causes presentation of a STEP 2 screen 1900(FIG. 19). The STEP 1 screen 1800 also includes a user-selectable logouticon 1816. Selection of the logout icon 1816 causes the user to belogged out of the assay device.

Various screens described below include some fields and/or icons thatare identical or similar to other screens. Such fields or icons areidentified in the Figures with common reference numbers. In the interestof clarity and brevity, only significant differences between the variousscreens will be discussed.

FIG. 19 shows a STEP 2 screen 1900 of a user interface of the assaydevice, according to one illustrated embodiment. The STEP 2 screen 1900includes a step 2 dialog box 1902 which displays acts or stepsassociated with step two. For example, the acts may include: A) executesample preparation, B) scan tube, C) place test strip in tube, D) scantest strip, E) repeating the execute, scan, place and scan for remainingsamples and finally F) start a timer. The STEP 2 screen 1900 may includescan tube fields 1904 (only one called out in FIG. 19) to displayidentifiers read from tubes and scan strip fields 1906 (only one calledout in FIG. 19) to display identifiers read from assay strips. The STEP2 screen 1900 also includes a user-selectable start timer icon 1920,selection of which will cause the assay device to start a timer. TheSTEP 2 may include a user-selectable back icon 1918, selection of whichallows the user to move back to the STEP 1 screen 1800.

FIG. 20 shows the STEP 2 screen 1900 after selection of the start timericon 1920. The dialog box 1902 displays a time of the timer, forexample, counting down or counting up.

FIG. 21 shows a STEP 3 screen 2100 of a user interface of an assaydevice, according to one illustrated embodiment. The STEP 3 screen 2100includes a dialog box 2102, displaying acts or steps associated with astep 3. For example, step 3 may include: A) a transfer of test strips toreader slots; and B) imaging of test strips in the slots, as well asreading of identifiers associated with the respective reader slots. TheSTEP 3 screen 2100 includes scan strip fields 2104 (only one called outin FIG. 21) for displaying identifiers read from assay strips. The STEP3 screen 2100 also includes scan slot fields 2106 (only one called outin FIG. 21) for displaying identifiers read from slots of the assaydevice. The STEP 3 screen 2100 further includes a user-selectable runtest icon 2108. Selection of the run test icon 2108 causes the assaydevice to perform an assay or evaluation of the assay strips.

FIG. 22 shows a results screen 2200 of a user interface of an assaydevice, according to one illustrated embodiment. The results screen 2200may include a number of results fields 2202 (only once called out inFIG. 22), one for each assay strip that was analyzed. The results fields2202 includes an image field 2203 (only one called out in FIG. 22) whichincludes an image of the particular assay strip. A positive resultssignal line 2306 and a control signal line 2308 are clearly visible inthe high resolution image 2304. Associated with each result field 2202,is an indication of the result 2204 a, 2204 b, collectively 2204. Theindications of the result 2204 provide visual feedback on the outcome ofthe assay. For example, a negative result indication 2204 a may bedisplayed in a first color (e.g., green), include a negative sign aswell as the word “NEGATIVE.” A positive result indication 2204 b may bedisplayed in a different color (e.g., red), include a plus sign, and theword “POSITIVE.” Each of the results fields 2202 may include auser-selectable details icon 2206. Selection of the details icon 2206brings up a details screen 2300 (FIG. 23) for the particular assaystrip.

The results screen 2200 may also include verify fields or icons 2208(only one called out in FIG. 22). The user may indicate verification ofindividual results by selecting the respective verify field or icon2208. The results screen 2200 may further include a verify all resultsicon or field 2210. A user may indicate verification of all of theresults by selecting the verify all field or icon 2210.

The results screen 2200 may also include a user-selectable new test icon2212. Selection of the new test icon 2212 returns the user to the STEP 1screen 1800 with all fields initialized.

FIG. 23 shows details screen 2300 for assay strip in which a positiveresult was determined, according to one illustrated embodiment. Thedetails screen 2300 includes an image field 2302 (only one called out inFIG. 22) which includes a high resolution image 2304 of the particularassay strip. A positive results signal line 2306 and a control signalline 2308 are clearly visible in the high resolution image 2304. Thedetail screen 2300 also includes a results field 2310, displaying theoutcome of the assay for the assay strip. The result field 2310 may, forexample, display a message which indicates that bacterial contaminationwas detected 2310 a, a plus sign 2310 b, and the word “POSITIVE” 2310 cto provide a clear indication of the outcome. The result field 2310 mayemploy a particular color (e.g., red) to further emphasize of results.The detail screen 2300 may further include a details dialog box 2312including relevant information. Such information may include a sampleidentifier 2312 a, indication of a time and date of a scan 2312 b, anindication of results 2312 c, an indication of a test line density 2312d, and an indication of a control line density 2312 e.

FIG. 24 shows the details screen 2400 for another assay strip in which anegative result was determined, according to one illustrated embodiment.The detail screen 2400 includes the same fields and icons as the detailscreen 2300. The content of the fields, dialog boxes, are updated toreflect the different assay strip and result. For example, the resultsdialog box 2310 may include a message which indicates that no bacterialcontamination was detected 2310 a, a negative sign 2310 b, and the word“NEGATIVE” 2310 c. The results field 2310 may employ a particular color(e.g., green) to further emphasis the result. Likewise, the detailsdialog box 2312 may include information that correctly identifies therespective assay strip, time and date of analysis, and results.

FIG. 25 shows a detail screen 2500 of a user interface of an assaydevice, according to another illustrated embodiment. The detail screen2500 may present data in a different fashion than the detail screen 2300(FIG. 23) and detail screen 2400 (FIG. 24). For example, a resultsdialog box 2510 may provide a pass/no pass indication 2510 a indicatingwhether the particular assay strip has passed or not passed. Likewise,the results dialog box 2510 may include an iconic representation of apass or no pass status 2510 b and may employ different colors fordifferent outcomes. In some embodiments, outcomes may include aninconclusive outcome in addition to the pass and no pass outcomes. Thedetail screen 2500 may present pass information as well asidentification information and scan time and date in a details dialogbox 2312.

FIG. 26 shows a first instruction screen 2600 of a user interface of anassay device, according to another illustrated embodiment. Aninstructions dialog box 2602 contains a set of instructions 2602 a thatare different from the set of instructions in the instruction dialog box1802 of the STEP 1 one instruction screen 1800 (FIG. 18). For example,instead of instructing that a kit number be entered, the instructiondialog box 2602 indicates that A) the kit number should be scanned. Theinstructions 2602 a include B) enter a number of samples to be tested,C) scan platelet bag, D) collect platelet sample in tube and scan, andE) repeat C & D for remaining samples. Notably, the instruction dialogbox 2602 also collects the separate acts or steps of the dialog box 1802into a single act or step (labeled D). In some embodiments, entering thenumber of samples may be optional, since the number of assay strips maybe determined via the image processing. The first instruction screen2600 also includes a pull-down menu 2612 for selecting the number ofsamples.

FIG. 27 shows a second instruction screen 2700 of a user interface of anassay device, according to one illustrated embodiment. The secondinstruction screen 2700 provides instructions 2602 b for preparingsamples which correspond to some of the instructions in the step twoinstruction screen 1900 (FIG. 19). The instruction dialog box 2602instructs a user to add drops of reagent and to incubate including: A)adding reagent and B) incubate including a prompt to the end user tostart a timer by selecting the start timer icon 1920. Selection of thestart timer icon 1920 causes the assay device to start a timer set tothe time indicated in the instructions 2602 b. The second instructionscreen 2700 also includes scan tube fields 2704 (only one called out inFIG. 27) to display identifiers read from tubes and scan strip fields2706 (only one called out in FIG. 27) to display identifiers read fromspecific assay strips.

FIG. 28 shows a third instruction screen 2800 of a user interface of anassay device according to one illustrated embodiment. The instructiondialog box 2600 provides further instructions 2602 c for preparingsamples to be tested or assayed. Instructions may include: C)centrifuging a tube, D) decant supernatant, and E) Incubated, includinga prompt to start a timer by selecting the start timer icon 1920.Selection of the start timer icon 1920 causes the assay device to starta timer set to the time indicated in the instructions 2602 c.

FIG. 29 shows a fourth instruction screen 2900 of a user interface of anassay device, according to one illustrated embodiment. The instructiondialog box 2602 displays further instructions 2602 d for preparingsamples to be tested or assayed. For instance, the instructions 2602 dmay include allowing tube to cool, including a prompt to the user tostart a time by selecting the start timer icon 1920. Selection of thestart timer icon 1920 causes the assay device to start a timer set tothe time indicated in the instructions 2602 d.

FIG. 30 shows a fifth instruction screen 3000 of a user interface of anassay device, according to one illustrated embodiment. The instructiondialog box 2602 displays further instructions 2602 e for preparingsamples to be tested or assayed. The instructions 2602 e may include G)adding reagents and H) incubating with a prompt to the user to stat atime by selecting the start timer icon 1920. Selection of the starttimer icon 1920 causes the assay device to start a timer set to the timeindicated in the instructions 2602 e.

FIG. 31 shows a sixth instruction screen 3100 of a user interface of anassay device, according to one illustrated embodiment. The instructionsdialog box 2602 displays even further instructions 2602 f for preparingsamples to be tested or assayed. Instructions 2602 f may include H) addrehydrated color reagent and J) incubate including a prompt to the userto stat a time by selecting the start timer icon 1920. Selection of thestart timer icon 1920 causes the assay device to start a timer set tothe time indicated in the instructions 2602 f.

FIG. 32 shows a seventh instruction screen 3200 of a user interface ofan assay device, according to one illustrated embodiment. Theinstructions dialog box 2602 displays instructions 2602 g, including K)reading identifiers from sample tubes, L) reading identifiers from testor assay strips, and M) placing the test or assay strips into sampletubes, along with a prompt to start a timer, for example, by selectinguser-selectable start timer icon 1920. Selection of the start timer icon1920 causes the assay device to start a timer set to the time indicatedin the instructions 2602 g. Notably, the instructions 2602 g correspondto instructions labeled D-F of the step two instruction screen 1900(FIG. 19).

FIG. 33 shows an eighth instruction screen 3300 of a user interface ofan assay device, according to one illustrated embodiment. Theinstruction dialog box 2602 displays instructions 2602 h, including N)prompting the user to transfer test or assay strips to slots in theassay device, and O) prompting the user to start the test by selectingthe user-selectable run test icon 1920. Notably, the instructions 2602 hcorrespond to the instructions of the step three instruction screen 2100(FIG. 21).

FIG. 34 shows an analyzing screen 3400 which may be displayed while theassay device performs analysis, providing the end user with visualfeedback indicating that the assay device is processing samples.

FIG. 35 shows a portion 3500 of a graphical user interface which may bedisplayed by an assay device or supporting computer, according to oneillustrated embodiment. The portion 3500 of the user interface includesa user-selectable manufacturer selection tab 3502 which may appear on acontrol bar of a user interface. Selection of the manufacturer selectiontab 3502 causes the presentation of a manufacturer pull-down menu 3504,which displays a list of assay strip manufacturers or distributors 3506(only one called out in FIG. 35). A user selectable sub-menu icon 3508is present if there are multiple options for a given assay stripmanufacturer or distributor 3506. Selection of the sub-menu icon 3508causes presentation of a model pull-down menu 3510. The model pull-downmenu 3510 presents a user selectable model icon 3512 a, 3512 b for eachmodel of assay strips produced or sold by the manufacturer ordistributor. Selection of a model icon 3512 a, 3512 b causes the assaydevice to retrieve specific parameters and variables for the selectedassay strip product and to configure the processor executableinstructions to perform assays based on the retrieved parameters andvariables. The specific parameters and variable for different productsmay be stored at the assay device, or may be stored remotely therefrom.In some embodiments, that assay device may automatically querymanufacturers or distributors (e.g., Website) for specific parametersand variables in response to the selection. In some embodiments,manufacturer/distributors (e.g., server) may transmit (i.e., push)specific parameters and variables to assay devices as products areupdated or introduced. This may eliminate the need for the operator orend user to download (i.e., pull) such parameters and variables.

FIG. 36 shows a portion 3600 of a graphical user interface which may bedisplayed by an assay device or supporting computer, according to oneillustrated embodiment. The portion 3600 of the user interface includesa user-selectable format selection tab 3602 which may appear on acontrol bar of a user interface. Selection of the format selection tab3602 causes the presentation of a format pull-down menu 3604, whichdisplays a list of format options 3606 (only one called out in FIG. 36).A user selectable sub-menu icon 3608 is present if there are multiplechoices for a given format option 3606. Selection of the sub-menu icon3608 (e.g., size) causes presentation of a format choices pull-down menu3610. The format choices pull-down menu 3610 presents a user selectableformat choices icon 3612 a-3612 e for each choice of format for theselected format option. Selection of a format choices icon 3612 a-3612 ecauses the assay device to retrieve specific parameters and variablesfor the selected format choice and to configure the processor executableinstructions to perform assays based on the retrieved parameters andvariables. The format pull-down menu 3604 may include numerous otheroptions for configuring the assay device to perform assays.

FIG. 37 shows a report 3700 generated by an assay system according toone illustrated embodiment.

In particular, FIG. 37 illustrates the use of an assay system to quicklyand efficiently test for multiple banned substances in a specimen. Forexample, an assay system may be used to test for instances of drugs ofabuse in a urine specimen. The specimen may be held in a container ofcup along with one or more assay strips. Advantageously, a single assaystrip with multiple assays or test and control lines may be employed.Thus, for example, a holder 3710 may hold multiple assay strips 3712a-3712 e (only two called out in FIG. 37), some of which assay strips3712 a, 3712 e may have assays for two or more substances (e.g., assaystrip 3712 a: BZO, MTD, BAR; assay strip 3712 e: mAmp, COC, THC).

The assay system may also establish a “chain-of-custody” by, forinstance, reading or receiving unique identification informationidentifying an individual being tested or otherwise associated with aspecimen and logically associating such unique identificationinformation with the results of the analysis and/or with the images onwhich the analysis is based. A time stamp 3714 may be useful inestablishing chain-of-custody.

The report 3700 may include identification information 3702 identifyingthe individual being subjected to testing. The identificationinformation 3702 may be read or captured directly from an individualbeing subjected to testing or from identification material, such asgovernment issued identification (e.g., drivers license, identity card,passport, military identification card), issued to the individual beingsubjected to testing. For example, the assay system may include or maybe communicatively coupled to a reader that automatically readsinformation identifying information, either from the individual directlyand/or from identification carried by or otherwise associated with theindividual. The reader may include a sensor or transducer, for examplean optical sensor or transducer and/or an audio sensor or transducer.The reader may read or capture biometric data or characteristics of theindividual, for instance, a digital fingerprint, iris scan, facial scan,voiceprint, other physiological data, etc. The reader may read orcapture an identifier from a piece of identification, for example byscanning or imaging the piece of identification. For instance, thereader may take the form of a machine-readable symbol reader such as abarcode scanner or imager to read machine-readable symbols (e.g.,barcode symbols, area or matrix code symbols, stacked code symbols).Additionally or alternatively, the reader may take the form of a radiofrequency identification (RFID) reader or interrogator to wirelesslyread identification information from a wireless transponder such as anRFID tag, for instance via radio or microwave signals. The reader mayadditionally or alternatively take other forms, for instance an image orscanning for capturing human-readable information and pictures carriedby the piece of identification. Additionally, or alternatively, theassay system may include or may be coupled to a user input device suchas a keyboard or keypad which allows a user to enter identificationinformation, which may, for example, be read by the user from a piece ofidentification carried by or otherwise associated with the individualbeing subjected to testing. Additionally, or alternatively, historiesfor the individual may be logically associated with the analysis. Forinstance, a patient history or a history of prior testing or analysismay be logically associated with the current analysis, and mayoptionally be reflected in report 3700.

The report 3700 may include a summary of assay results 3704. The summaryof assay results 3704 may provide an abbreviated version of some or allof the results of the analysis performed. For example, the summary ofassay results 3704 may simply indicate whether results where positive ornegative.

The report 3700 may include a detailed listing of assay results 3706.The detailed listing of assay results 3706 may provide detailedinformation about all of the analysis. For example, detailed listing ofassay results 3706 may provide density values, threshold values andresults for each separate assay or control line of the particular assayor assay strip.

The report 3700 may include an image 3708 of the assay strip or strips.The image 3708 may show the results of multiple assays used to identifythe presence and/or absence of multiple drugs of abuse from a singlespecimen. The image 3708 may also show identifying information, forexample a machine-readable symbol that encodes a unique identifier thatidentifies the particular assay or assay strip. Such may be logicallyassociated with an identifier that uniquely identifies the individualbeing subjected to the testing. While discussed herein as being used ona human individual, assay testing may be used on non-human animals aswell, for example race horses.

FIG. 38 shows an assay system 3800 for use with a container 3802,according to one illustrated embodiment.

The assay system 3800 may be similar to the previously described assaysystems, however includes at least one opening or slot 3804 sized to atleast partially receive the container 3802 therein.

FIG. 39 shows a container 3902, according to one illustrated embodiment.

The container 3902 contains or holds a specimen 3904, for example abodily substance, for instance a bodily fluid such as urine or blood,taken or collected from an individual who is undergoing testing. Thecontainer 3902 may hold a strip carrier 3906 that carries one or moreassay strips 3908 a-3908 c (only three called out in FIG. 39,collectively referred to as 3908). The assay strips 3908 may be similarto those previously described. Alternatively, the assay strips 3908 maybe held in the container 3902, either in a free state or attached to thewall of the container 3902. The strip carrier 3906 may include variousindicia, generally indicated as 3910. The indicia 3910 may, for example,identify a manufacturer and/or a test, as well as identify the variousanalysis or substances being tested for at various locations on thestrip carrier 3906. For instance, an indication “OPI” may indicate atest for opiates, and indication “PCP” for the drug PCP, “AMP” foramphetamines, “COC” for cocaine, and “THC” for the active ingredient incannabis. The strip carrier 3906 and/or the container may includeidentifying indicia 3912, which may be in machine-readable form such asa one- or two-dimensional symbol (e.g., barcode symbol, area or matrixcode symbol, or stacked code symbol) and/or in human-readable form. Suchmay uniquely identify an individual from which the specimen was taken orcollected, for example via a database that maps a unique identifier tothe individual by name and/or identification number (e.g., socialsecurity number, driver's license number, employee number).

The container 3902 may include a top or cover 3914 to seal the contentswithin the container 3902. The container 3902 may advantageously have arelative flat portion 3916, which may facilitate imaging or imagecapture of the assay strips. While FIG. 39 illustrates only one shapeand size of container, the assay system 3800 (FIG. 38) may accommodateany number of shapes and sizes of containers 3902. Further, while FIG.39 only illustrates on shape and size of strip carrier 3906, any varietyof shapes or sizes of strip carrier may be employed. Even further, anyshape, size or number of assay strips 3908 may be employed.

FIG. 40 shows a user interface of an assay system, according to oneillustrated embodiment.

The assay system 3800 (FIG. 38) may provide a user interface 4000 tofacilitate such variability, and ability to accommodate containers 3902and/or strip carriers 3906 and/or assay strips 3908 from a large varietyof manufacturers, producers or distributors. In particular, the assaysystem 3800 may have one or more user input devices, for instance one ormore menus with user selectable icons, which allows a user to configurethe assay system 3800 to analyze a particular container, strip carrierand/or assay strip. For instance, a pull-down menu 4002 may include alist of choices 4004 (only one called out in FIG. 40) which the user mayselect from. The choices 4004 may include selections indicative ofvarious container types (e.g., cups). The choices 4004 may includeselections indicative of various strip carrier formats (e.g., physicalsize, shape and/or position of assay strips on the strip carrier). Thechoices 4004 may include selections indicative of various assay strips(e.g., whether appearance or absence of line is a positive result,threshold, various substances being tested, size and dimension of assaystrip, location of control line, etc.)

Such may be particularly suited for testing for banned or illicitsubstances such as prohibited drugs. Thus, a specimen (e.g., urine) 3904may be collected in a container 3902 which holds an assay strip carrier3906 that in turn holds one or more assay strips 3908. The container issealed with the top or cover 3914, which may include a tamper resistanceor tamper indicative seal which indicates if the top or cover has beentampered with after sealing. The container 3902 may include identifyinginformation 3912, uniquely identifying the individual from which thespecimen was taken. Thus, a chain-of-custody may be established. Thecontents of the container 3902 may be automatically analyzed or assessedvia the assay system 3800, without opening the container 3902. Such maynot only ensure that the chain-of-custody has not be broken, but may bemore hygienic and efficient than other approaches to drug testing.

FIG. 41 shows a portion of a user interface in the form of a screen4100, according to one illustrated embodiment.

The screen 4100 includes a unique identifier field 4102 that allows auser to enter a unique identifier for the individual subjected totesting, a name field 4104 to enter the name of the individual subjectedto testing. The screen 4100 may include an employer identity field 4106that allows the user to enter an identity of an employer or prospectiveemployer for which the individual is being tested, or to select suchemployer or prospective employer identity from a drag down list. Thescreen 4100 may include a user selectable icon 4108 to cause the assaysystem 3800 (FIG. 3800) to run an assay or test using the user enteredidentity information.

FIG. 42 shows a portion of a user interface in the form of a screen4200, according to one illustrated embodiment.

The screen 4200 presents assay or test results. The screen 4200 mayinclude an indication of positive or negative results (e.g., pass/fail)for one or more assays, generally indicated as 42002. The screen 4200may include a high resolution image 4204 of the container, strip carrierand/or assay strips as captured by the assay system 3800 (FIG. 38). Thescreen 4200 may include user selectable checkboxes or other fields 4206to indicate whether the test should be verified or overridden. Thescreen 4200 includes a user selectable re-scan icon 4208, selection ofwhich causes the assay system 3800 to rescan the container and assaystrips contained therein. The screen 4200 includes a user selectable newtest icon 4210, selection of which causes the assay system 3800 toprocess a new container or run a different test on an existingcontainer. The screen 4200 includes a user selectable logout icon 4208,selection of which causes the assay system 3800 to log out a currentuser.

FIG. 43 shows a database 4300 according to one illustrated embodiment.

The database 4300 stores information 43002 (only one test or assayshown) related to tests or assays. Additional rows of information may beadded to the database 4300 as additional specimens are processed.Information may include a package identifier (col. 1), a first patientidentifier (col. 2) such as a unique identifier, a second patientidentifier (col. 3) such as given and surname, and employer identifier(col. 4) and/or a package type identifier (col. 5) identifying the typeof container and/or strip carrier. The information may also include auser identifier (col. 6) identifying the operator of the assay deviceduring the specific assay, a date/time of the test or analysis (col. 7),an indication of the results of the test or analysis (col. 8), anindication of a user selected override result (col. 9), an indication ofthe actual line results (col. 10), an indication of whether the resultswere verified (col. 11), and/or an indication of whether adulterationoccurred (col. 12).

The database 4300 also stores a copy of the high resolution image 4304upon which the analysis or assay was performed.

A user selectable icon 4306 may allow user to print or export all of thedata. A user selectable icon 4308 may allow user to print or export aselection portion of the data. A user selectable icon 4310 may allowuser to edit the data.

The above description of illustrated embodiments, including what isdescribed in the Abstract, is not intended to be exhaustive or to limitthe embodiments to the precise forms disclosed. Although specificembodiments of and examples are described herein for illustrativepurposes, various equivalent modifications can be made without departingfrom the spirit and scope of the disclosure, as will be recognized bythose skilled in the relevant art. The teachings provided herein of thevarious embodiments can be applied to other assay systems, notnecessarily the exemplary lateral flow immunochromatographic assay stripsystem generally described above.

For example, the apparatus and/or method of acquiring an image may bedifferent. For instance, a different model of scanner or imager could beused, such as a Fujitsu fi-60F scanner. In particular, the assay systemmay be altered to use a variety of optical scanning devices or imagersin place of the Avision AVA6+. The software could use a different drivermodel to communicate with the scanner or imager (e.g., WIA or SANE). Thescanner or imager could be accessed remotely over a network instead of adirect cable connection. Also for instance, the parameters of the scanor imaging, such as color depth and resolution, could be modified; orthe image could be acquired from a digital camera, frame grabber, orother acquisition device, or from a memory card, hard drive, or otherstorage device.

Also for example, the presence or type of machine-readable symbolsand/or the apparatus and/or methods used to read them may be different.For instance, if the assay system did not employ machine-readablesymbols such as barcode symbols, the assay system could alternativelyrely on the user to explicitly indicate which identifying data setbelongs to each assay strip. The user could do such via suitable userinput device, for example entering identity information in fields on ascreen via a keyboard or keypad, or other user input device. Thus,various identity fields (e.g., scan bag 1804, scan tube 1806, scan strip1906, scan slot 2006) in various screens may not only displayidentifiers, by may allow the user to manually enter the appropriateidentifiers via a user input device.

Also for example, the analysis algorithm can be customized to adapt toany given lateral flow immunochromatographic test strip. Also forexample, the method used to locate assay strips within the entirescanned image may be modified. For instance, the acceptable range ofhue, saturation, and brightness for each type of blob could be changed.Also for instance; the noise reduction methods could be changed. Theexpected weights of blobs or expected distances between blobs could bechanged. The expected arrangement of blobs could be altered to detect adifferent series of assay strips. Indeed, searching the acquired imagefor the assay strip(s) (e.g., 106-1020, FIG. 10A) could be omittedcompletely. The assay device could alternatively locate the windows ofeach assay strip based on information provided by the user orcalibration performed at the factory. For example, the user may identifythe assay strip (e.g., center, boundary or periphery) by entering one ormore points, lines or curves via a suitable user input device such as atouch screen or pointer device.

Also for example, any number of additional iterations of pixeltransformation based on additional colors and/or blob analysis on theresults of the additional iterations of pixel transformation may beperformed. Such additional iterations may advantageously be employed toidentify different or multiple assay types. Such may be based, forexample, on specifications set out in data structures, such ascustomized templates.

Also for example, the specific data structures used to store blob andstrip locations and represent the signal graph may be modified. Asexplained above, a template may be customized for each new assay typewhich the assay device is to recognize. In this way, the assay devicemay be reconfigured to recognize newly developed assay types or existingassay types which may become of interest to the operator of the assaydevice. Such may also accommodate new or different test strip physicalor geometric configurations.

Also for example, the specific order of the acts used to produce thesignal graph may be varied, some of the acts may be omitted, and/oradditional acts may be performed. For instance, shadow detection couldbe eliminated or the assay system may assume a fixed-size shadow. Alsofor instance, the assay strips could be oriented horizontally instead ofvertically. Also for instance, the enhanced average could be defined asthe mean brightness for all rows.

Also for example, the method of locating the control and test backgroundlines may be different. For instance, the endpoints could be moved, orthe lines could be curved instead of straight.

As another example, the method of determining the line densities andmaking an assessment based on the values obtained in method 1040 (FIG.10C), for instance at 1048-1064, may be different. For instance, thecontrol line density could be based on some combination of A and Binstead of CP and CB.

As yet another example, the specific values of all ranges and thresholdsmay be different or modified. For instance, a different assay strip typemight require a different location for the control window, a differentdistance between the control and test windows, a different test linedensity indicative of a positive result, etc.

As a further example, the presence of a database or the contents of therecords may be different than described above.

As yet a further example assay strips may take the form of any mediumcapable of being assayed, analyzed or otherwise evaluated for thepresence or absence of an analyte. Examples of assay strips includechromatographic lateral flow strips or lateral flow strips, westernblots, southern blots, electrophoresis gels, dot blots, etc. Some assaystrips may produce a visible indication (e.g., a test result signal) inresponse to an absence of a particular substance, for example absence ofa banned substance such as a drug, from a sample being tested. Assaystrips which include inhibition assays may be employed. Assay strips mayindicates a presence of a particular substance by an absence of aresults line or other marking or indication.

Hence, described is apparatus, methods and articles that can accuratelydetect the presence or absence of test result or control signal lines ina non-subjective manner, while eliminating the misinterpretation of highbackground levels as a positive result. This is accomplished by a uniquemethod of signal line detection and for background subtraction. Such maybe customized to address any format of lateral flowimmunochromatographic assay. In addition, all data and results arestored in an electronic database for future reference and verification.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, schematics,and examples. Insofar as such block diagrams, schematics, and examplescontain one or more functions and/or operations, it will be understoodby those skilled in the art that each function and/or operation withinsuch block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In one embodiment, thepresent subject matter may be implemented via Application SpecificIntegrated Circuits (ASICs). However, those skilled in the art willrecognize that the embodiments disclosed herein, in whole or in part,can be equivalently implemented in standard integrated circuits, as oneor more computer programs running on one or more computers (e.g., as oneor more programs running on one or more computer systems), as one ormore programs running on one or more controllers (e.g.,microcontrollers) as one or more programs running on one or moreprocessors (e.g., microprocessors), as firmware, or as virtually anycombination thereof, and that designing the circuitry and/or writing thecode for the software and or firmware would be well within the skill ofone of ordinary skill in the art in light of this disclosure.

In addition, those skilled in the art will appreciate that themechanisms taught herein are capable of being distributed as a programproduct in a variety of forms, and that an illustrative embodimentapplies equally regardless of the particular type of signal bearingmedia used to actually carry out the distribution. Examples of signalbearing media include, but are not limited to, the following: recordabletype media such as floppy disks, hard disk drives, CD ROMs, digitaltape, and computer memory; and transmission type media such as digitaland analog communication links using TDM or IP based communication links(e.g., packet links).

The various embodiments described above can be combined to providefurther embodiments. To the extent that they are not inconsistent withthe specific teachings and definitions herein, all of the U.S. patents,U.S. patent application publications, U.S. patent applications, foreignpatents, foreign patent applications and non-patent publicationsreferred to in this specification and/or listed in the Application DataSheet, are incorporated herein by reference, in their entirety. Aspectsof the embodiments can be modified, if necessary, to employ systems,circuits and concepts of the various patents, applications andpublications to provide yet further embodiments.

These and other changes can be made to the embodiments in light of theabove-detailed description. In general, in the following claims, theterms used should not be construed to limit the claims to the specificembodiments disclosed in the specification and the claims, but should beconstrued to include all possible embodiments along with the full scopeof equivalents to which such claims are entitled. Accordingly, theclaims are not limited by the disclosure.

1. An assay system to perform assays using assay strips, the assaysystem comprising: at least one sealed specimen collection containerhaving fluidly sealed therein a specimen and at least one assay strip; ahousing having an interior and at least one aperture providing access tothe interior, the at least one aperture sized to receive at least aportion of the at least one sealed specimen collection container; animager subsystem operable to capture images of any of the assay stripsreceived in the interior of the housing; and a processor subsystemcomprising at least one processor and at least one processor-readablememory communicatively coupled to the at least one processor, the atleast one processor also communicatively coupled to the imager subsystemto receive image information representative of the images captured bythe imager subsystem, the at least one processor configured to identifyindividual ones of the assay strips in the image from the imageinformation, the at least one processor further configured to perform anobjective assay evaluation based at least in part on at least one signalline on each of the assay strips and based at least in part on at leastone configurable criteria.
 2. The assay system of claim 1 wherein the atleast one processor further stores a respective high resolution digitalrepresentation of the captured image of each of at least some of theassay strips to a non-transitory, computer-readable storage medium alongwith at least some identification information logically associated withthe respective high resolution digital representation of the capturedimage of each of the at least some of the assay strips.
 3. The assaysystem of claim 1 wherein the at least one processor further stores arespective high resolution digital representation of the captured imageof each of at least some of the assay strips to a non-transitory,computer-readable storage medium along with at least some informationindicative of a result of the objective assay evaluation for each of atleast some of the assay strips logically associated with the respectivehigh resolution digital representation of the captured image of each ofthe at least some of the assay strips.
 4. The assay system of claim 1wherein the at least one processor identifies individual ones of theassay strips in the image from the image information, by: a firstiteration of pixel transformation based on a first color of a pluralityof pixels; a first iteration of blob analysis on a set of the pluralityof pixels resulting from the first iteration of pixel transformation toidentify a first number of blobs; a first iteration of blob pairing onthe first number of blobs identified in the first iteration of blobanalysis; a second iteration of pixel transformation based on a secondcolor of a plurality of pixels; a second iteration of blob analysis on aset of the plurality of pixels resulting from the second iteration ofpixel transformation to identify a second number of blobs; and a seconditeration of blob pairing on the second number of blobs identified inthe second iteration of blob analysis.
 5. The assay system of claim 1wherein the at least one processor further identifies anymachine-readable symbols in the image from the image information, anddecodes the identified machine-readable symbols, if any.
 6. The assaysystem of claim 1, further comprising: a user interface including anumber of user selectable inputs that correspond to respective ones of anumber of configuration modes, where in response to selection of one ofthe user selectable inputs the processor subsystem reconfigures theconfigurable criterion.
 7. The assay system of claim 6 wherein the userinterface includes at least one input device configured to allow theentry of a subject identifier that uniquely identifies a subject fromwhich a sample on the assay strip was taken, and wherein the at leastone processor is configured to store a logical association between theobjective assay evaluation of the assay strip and the subjectidentifier.
 8. The assay system of claim 6 wherein the user interfaceincludes at least one input device configured to allow the entry of aselection that identifies a type of data carrier, and wherein the atleast one processor is configured to process based on the type of datacarrier indicated by the entry.
 9. The assay system of claim 1 whereinthe image subsystem includes a two dimensional array that images an areagreater than an area of a single assay strip.
 10. The assay system ofclaim 1 wherein the imager subsystem includes a fixed CCD or CMOS imagecapture device able to provide at least one two-dimensional data arrayrepresentative of an image of at least a portion of the specimencontainer and the at least one assay strip received in the interior ofthe housing.
 11. The assay system of claim 1 wherein the imagersubsystem includes a mechanical or electromechanical scanning deviceable to provide a number of one-dimensional data arrays representativeof at least a portion of an image of the specimen container and the atleast one assay strip received in the interior of the housing.
 12. Amethod of operating an assay system having at least one processor toperform assays of assay strips, the method comprising: receiving in aninterior of a housing at least a portion of a sealed container having aspecimen along with at least one assay strip fluidly sealed therein,wherein the portion of the sealed specimen collection container receivedin the interior of the housing includes the at least one assay strip;capturing at least one high resolution image of a portion of theinterior of the housing in which the sealed specimen collectioncontainer is received; computationally identifying individual ones ofthe assay strips in the captured high resolution image; andcomputationally performing the objective assay evaluation for each ofthe identified individual ones of the assay strips that appear in thecaptured high resolution image based at least in part on arepresentation of at least one signal line of each of the assay stripsin the captured high resolution image.
 13. The method of claim 12wherein capturing at least one high resolution image in the interior ofthe housing includes capturing at least one high resolution image of anarea in the interior of the housing having a length and a width that isgreater than a length and a width of at least two adjacent assay strips.14. The assay method of claim 12 wherein capturing at least one highresolution image of a portion of the interior of the housing in whichthe sealed specimen collection container is received comprises capturinga two-dimensional data array, the two dimensional data array includingdata representative of an image of at least a portion of the specimencontainer and the at least one assay strip received in the interior ofthe housing via a fixed CCD or CMOS image capture device.
 15. The assaymethod of claim 12 wherein capturing at least one high resolution imageof a portion of the interior of the housing in which the sealed specimencollection container is received comprises capturing a number ofone-dimensional data arrays, each of the number of one-dimensional dataarrays including data representative of at least a portion of an imageof the specimen container and the at least one assay strip received inthe interior of the housing via a moveable electrical orelectromechanical scanning device.
 16. The method of claim 12 whereincomputationally identifying individual ones of the assay strips in thecaptured high resolution image comprises: performing a first iterationof pixel transformation based on a first color of a plurality of pixelsin the high resolution image; performing a first iteration of blobanalysis on a of the plurality of pixels resulting from the firstiteration of pixel transformation to identify a first number of blobs;performing a first iteration of blob pairing on the first number ofblobs identified in the first iteration of blob analysis; performing asecond iteration of pixel transformation based on a second color of aplurality of pixels; performing a second iteration of blob analysis on aof the plurality of pixels resulting from the second iteration of pixeltransformation to identify a second number of blobs; and performing asecond iteration of blob pairing on the second number of blobsidentified in the second iteration of blob analysis.
 17. The method ofclaim 12, further comprising: identifying any machine-readable symbolsin the captured high resolution image; decoding the identifiedmachine-readable symbols, if any; and logically associatingidentification information decoded from the identified machine readablesymbols with respective ones of the assay strips which appear in thehigh resolution image.
 18. The method of claim 12, further comprising:storing a respective digital representation of a portion of the capturedhigh resolution image of each of at least some of the assay strips to anon-transitory computer-readable storage medium along with at least someidentification information logically associated with the respectivedigital representation of the respective portion of the captured highresolution image of each of the at least some of the assay strips. 19.The method of claim 12, further comprising: storing a respective digitalrepresentation of a portion of the captured high resolution image ofeach of at least some of the assay strips to a non-transitorycomputer-readable storage medium along with at least some informationindicative of a result of the objective assay evaluation for each of atleast some of the assay strips logically associated with the respectivedigital representation of the respective portion of the captured highresolution image of each of the at least some of the assay strips. 20.The method of claim 12, further comprising: reading a subject identifierin the form of a piece of biometric information or a piece of governmentissued identification; and storing a logical association between theobjective assay evaluation of the assay strip and the subjectidentifier.
 21. A method of operating an assay system having at leastone processor to perform an autonomous assay analysis on at least oneassay strips, the method comprising: receiving on a one-for-one basis, anumber of loose assay strips into an interior of a housing via acorresponding number of apertures; capturing at least one highresolution image of a portion of the interior of the housing in whichthe assay strips are received; computationally identifying individualones of the assay strips in the captured high resolution image; andcomputationally performing the objective assay evaluation for each ofthe identified individual ones of the assay strips that appear in thecaptured high resolution image based at least in part on arepresentation of at least one signal line of each of the assay stripsin the captured high resolution image.
 22. The method of claim 21wherein receiving on a one-for-one basis a number of loose assay stripsin an interior of a housing includes receiving a plurality of assaystrips in the housing arranged such that at least a portion of each of aplurality of flow strips is exposed to an imager.
 23. The method ofclaim 21 wherein capturing at least one image in the interior of thehousing includes capturing at least one image of an area in the interiorof the housing having a dimension that is greater than a dimension of asingle assay strip.
 24. The method of claim 21 wherein capturing atleast one high resolution image in the interior of the housing includescapturing at least one high resolution image of an area in the interiorof the housing having a length and a width that is greater than a lengthand a width of at least two adjacent assay strips.
 25. The method ofclaim 21 wherein capturing at least one high resolution image of aportion of the interior of the housing in which the assay strips arereceived comprises capturing at least one two-dimensional data array,the at least one two-dimensional data array including datarepresentative of an image of at least a portion of the specimencontainer and the at least one assay strip received in the interior ofthe housing via a fixed CCD or CMOS image capture device.
 26. The methodof claim 21 wherein capturing at least one high resolution image of aportion of the interior of the housing in which the assay strips arereceived comprises capturing a number of one-dimensional data arrayseach of the number of one-dimensional data arrays including datarepresentative of at least a portion of an image of the specimencontainer and the at least one assay strip received in the interior ofthe housing via a moveable mechanical or electromechanical scanningdevice.
 27. The method of claim 21 wherein computationally identifyingindividual ones of the assay strips in the captured high resolutionimage comprises: performing a first iteration of pixel transformationbased on a first color of a plurality of pixels in the high resolutionimage; performing a first iteration of blob analysis on a of theplurality of pixels resulting from the first iteration of pixeltransformation to identify a first number of blobs; and performing afirst iteration of blob pairing on the first number of blobs identifiedin the first iteration of blob analysis.
 28. The method of claim 21wherein computationally identifying individual ones of the assay stripsin the captured image further comprises: performing a second iterationof pixel transformation based on a second color of a plurality ofpixels; performing a second iteration of blob analysis on a of theplurality of pixels resulting from the second iteration of pixeltransformation to identify a second number of blobs; and performing asecond iteration of blob pairing on the second number of blobsidentified in the second iteration of blob analysis.
 29. The method ofclaim 21, further comprising: identifying any machine-readable symbolsin the captured high resolution image; and decoding the identifiedmachine-readable symbols, if any.
 30. The method of claim 29, furthercomprising: logically associating identification information decodedfrom the identified machine readable symbols with respective ones of theassay strips which appear in the high resolution image.
 31. The methodof claim 21, further comprising: storing a respective digitalrepresentation of a portion of the captured high resolution image ofeach of at least some of the assay strips to a non-transitorycomputer-readable storage medium along with at least some identificationinformation logically associated with the respective digitalrepresentation of the respective portion of the captured high resolutionimage of each of the at least some of the assay strips.
 32. The methodof claim 21, further comprising: storing a respective digitalrepresentation of a portion of the captured high resolution image ofeach of at least some of the assay strips to a non-transitorycomputer-readable storage medium along with at least some informationindicative of a result of the objective assay evaluation for each of atleast some of the assay strips logically associated with the respectivedigital representation of the respective portion of the captured highresolution image of each of the at least some of the assay strips. 33.The method of claim 32 wherein the storing includes storing to aremovable non-transitory computer-readable storage medium.
 34. Themethod of claim 21 wherein computationally performing the objectiveassay evaluation for each of the identified individual ones of the assaystrips that appear in the captured high resolution image based at leastin part on a representation of at least one signal line of each of theassay strips in the captured high resolution image includes objectivelyquantifying an intensity of at least one positive results signal line oneach of the assay strips represented in the captured high resolutionimage.
 35. The method of claim 21 wherein computationally performing theobjective assay evaluation for each of the identified individual ones ofthe assay strips that appear in the captured high resolution image basedat least in part on a representation of at least one signal line of eachof the assay strips in the captured high resolution image includesevaluating at least one control signal line on each of the assay stripsrepresented in the captured high resolution image.
 36. The method ofclaim 21, further comprising: reading a subject identifier in the formof a piece of biometric information or a piece of government issuedidentification; and storing a logical association between the objectiveassay evaluation of the assay strip and the subject identifier.
 37. Anon-transitory computer-readable medium that stores instructions thatcause an assay system having at least one processor to perform assays ofassay strips, by: capturing at least one high resolution image of aportion of the interior of the housing in which a number of assay stripsare received; performing a first iteration of pixel transformation basedon a first color of a plurality of pixels in the high resolution image;performing a first iteration of blob analysis on the plurality of pixelsresulting from the first iteration of pixel transformation to identify afirst number of blobs; and performing a first iteration of blob pairingon the first number of blobs identified in the first iteration of blobanalysis; and computationally performing the objective assay evaluationfor each of the identified individual ones of the assay strips thatappear in the captured high resolution image based at least in part on arepresentation of at least one signal line of each of the assay stripsin the captured high resolution image.
 38. The non-transitorycomputer-readable medium of claim 37 wherein computationally identifyingindividual ones of the assay strips in the captured image furthercomprises: performing a second iteration of pixel transformation basedon a second color of a plurality of pixels; performing a seconditeration of blob analysis on a of the plurality of pixels resultingfrom the second iteration of pixel transformation to identify a secondnumber of blobs; and performing a second iteration of blob pairing onthe second number of blobs identified in the second iteration of blobanalysis.
 39. The non-transitory computer-readable medium of claim 37where the instructions cause the assay system to perform assays of assaystrips, further by: identifying any machine-readable symbols in thecaptured high resolution image; and decoding the identifiedmachine-readable symbols, if any.
 40. The non-transitorycomputer-readable medium of claim 37 where the instructions cause theassay system to perform assays of assay strips, further by: logicallyassociating identification information decoded from the identifiedmachine readable symbols with respective ones of the assay strips whichappear in the high resolution image.
 41. The non-transitorycomputer-readable medium of claim 37 where the instructions cause theassay system to perform assays of assay strips, further by: storing arespective digital representation of a portion of the captured highresolution image of each of at least some of the assay strips to anon-transitory computer-readable storage medium along with at least someidentification information logically associated with the respectivedigital representation of the respective portion of the captured highresolution image of each of the at least some of the assay strips. 42.The non-transitory computer-readable medium of claim 37 where theinstructions cause the assay system to perform assays of assay strips,further by: storing a respective digital representation of a portion ofthe captured high resolution image of each of at least some of the assaystrips to a non-transitory computer-readable storage medium along withat least some information indicative of a result of the objective assayevaluation for each of at least some of the assay strips logicallyassociated with the respective digital representation of the respectiveportion of the captured high resolution image of each of the at leastsome of the assay strips.
 43. The non-transitory computer-readablemedium of claim 37 wherein computationally performing the objectiveassay evaluation for each of the identified individual ones of the assaystrips that appear in the captured high resolution image based at leastin part on a representation of at least one signal line of each of theassay strips in the captured high resolution image includes objectivelyquantifying an intensity of at least one positive results signal line oneach of the assay strips represented in the captured high resolutionimage.
 44. The non-transitory computer-readable medium of claim 37wherein computationally performing the objective assay evaluation foreach of the identified individual ones of the assay strips that appearin the captured high resolution image based at least in part on arepresentation of at least one signal line of each of the assay stripsin the captured high resolution image includes evaluating at least onecontrol signal line on each of the assay strips represented in thecaptured high resolution image.
 45. A method of operating an assaysystem having at least one processor to perform assays of assay strips,the method comprising: receiving a user input indicative of at least onevalue of at least one configurable criteria to be used in performing anobjective assay evaluation; receiving on a one-for-one basis, each of aplurality of loose assay strips into an interior of a housing viarespective ones of a plurality of apertures; capturing at least oneimage of a portion of the interior of the housing in which the assaystrips are received; and computationally performing the objective assayevaluation for each of the assay strips in the captured image based atleast in part on a representation of at least one signal line of each ofthe assay strips in the captured image and based at least in part on theuser input indicative of the at least one value of at least one userconfigurable criteria.
 46. The method of claim 45 wherein receiving auser input indicative of at least one value of at least one configurablecriteria to be used in performing an objective assay evaluation includesreceiving a user input indicative of a threshold level for the objectiveassay evaluation.
 47. The method of claim 45 wherein receiving a userinput indicative of at least one value of at least one configurablecriteria to be used in performing an objective assay evaluation includesreceiving a user input indicative of a threshold intensity level for apositive results signal line.
 48. The method of claim 45 whereinreceiving a user input indicative of at least one value of at least oneconfigurable criteria to be used in performing an objective assayevaluation includes receiving a value indicative of a physical format ofthe assay strips of the respective type of assay strip.
 49. The methodof claim 45 wherein receiving a user input indicative of at least onevalue of at least one configurable criteria to be used in performing anobjective assay evaluation includes receiving a value indicative of atype of assay strip.
 50. The method of claim 45 wherein receiving a userinput indicative of at least one value of at least one configurablecriteria to be used in performing an objective assay evaluation includesreceiving a value indicative of a assay strip manufacturer.
 51. Themethod of claim 45 wherein receiving on a one-for-one basis, each of aplurality of loose assay strips into an interior of a housing viarespective ones of a plurality of apertures includes receiving each ofthe plurality of loose assay strips in the housing arranged such that atleast a portion of each of a plurality of flow strips is exposed to animager.
 52. The method of claim 45 wherein capturing at least one imagein the interior of the housing includes capturing at least one image ofan area in the interior of the housing having a dimension that isgreater than a dimension of a single assay strip.
 53. The method ofclaim 45 wherein capturing at least one image in the interior of thehousing includes capturing at least one image of an area in the interiorof the housing having a length and a width that is greater than a lengthand a width of at least two adjacent assay strips.
 54. The method ofclaim 45, further comprising computationally identifying individual onesof the assay strips in the captured image.
 55. The method of claim 45wherein receiving a user input indicative of at least one value of atleast one configurable criteria to be used in performing an objectiveassay evaluation includes receiving an end user input via a userinterface.
 56. A non-transitory computer-readable medium that storesinstructions that cause an assay system having at least one processor toperform assays of assay strips, by: receiving a user input indicative ofat least one value of at least one configurable criteria to be used inperforming an objective assay evaluation; receiving on a one-for-onebasis, each of a plurality of loose assay strips into an interior of ahousing via respective ones of a plurality of apertures; capturing atleast one image a portion of the interior of the housing in which theassay strips are received; and computationally performing the objectiveassay evaluation for each of the assay strips in the captured imagebased at least in part on a representation of at least one signal lineof each of the assay strips in the captured image and based at least inpart on the user input indicative of the at least one value of at leastone user configurable criteria.
 57. The non-transitory computer-readablemedium of claim 56 wherein receiving a user input indicative of at leastone value of at least one configurable criteria to be used in performingan objective assay evaluation includes receiving a user input indicativeof a threshold level for the objective assay evaluation.
 58. Thenon-transitory computer-readable medium of claim 56 wherein receiving auser input indicative of at least one value of at least one configurablecriteria to be used in performing an objective assay evaluation includesreceiving a user input indicative of a threshold intensity level for apositive results signal line.
 59. The non-transitory computer-readablemedium of claim 56 wherein receiving a user input indicative of at leastone value of at least one configurable criteria to be used in performingan objective assay evaluation includes receiving a value indicative of aphysical format of the assay strips of the respective type of assaystrip.
 60. The non-transitory computer-readable medium of claim 56wherein receiving a user input indicative of at least one value of atleast one configurable criteria to be used in performing an objectiveassay evaluation includes receiving a value indicative of a type ofassay strip.
 61. The non-transitory computer-readable medium of claim 56wherein receiving a user input indicative of at least one value of atleast one configurable criteria to be used in performing an objectiveassay evaluation includes receiving a value indicative of a assay stripmanufacturer.
 62. The non-transitory computer-readable medium of claim56 wherein receiving on a one-for-one basis, each of a plurality ofloose assay strips into an interior of a housing via respective ones ofa plurality of apertures includes receiving each of the plurality ofloose assay strips in the housing arranged such that at least a portionof each of a plurality of flow strips is exposed to an imager.
 63. Thenon-transitory computer-readable medium of claim 56 wherein capturing atleast one image in the interior of the housing includes capturing atleast one image of an area in the interior of the housing having adimension that is greater than a dimension of a single assay strip. 64.The non-transitory computer-readable medium of claim 56 whereincapturing at least one image in the interior of the housing includescapturing at least one image of an area in the interior of the housinghaving a length and a width that is greater than a length and a width ofat least two adjacent assay strips.
 65. The non-transitorycomputer-readable medium of claim 56, further comprising:computationally identifying individual ones of the assay strips in thecaptured image.
 66. The non-transitory computer-readable medium of claim56 wherein receiving a user input indicative of at least one value of atleast one configurable criteria to be used in performing an objectiveassay evaluation includes receiving an end user input via a userinterface.